Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hypothermia

Urologic Neoplasms

Body Temperature Changes

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Micronutrients

Antineoplastic Agents

Vitamins

Anesthetics

Bupivacaine

Vitamin A

Retinol palmitate

Retinol

Patients covered with a 41 centigrade degrees double layered cotton cloth

Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation

Core temperature and 4-points skin temperatures measurements will be recorded all over the operation. Patients will be delivered 2 Litre/minute oxygen with a nasal cannula.Iv hydration will be continued by room temperatured balanced electrolyte solution with an infusion rate of 2mL/kg/hr. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position.

Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation

Negin Nayebi, MD

Zeki Tuncel Tekgül, Assoc Prof

Halide Hande Şahinkaya, Specialist

In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.

In this prospective single-blind study, patients will be divided into 2 groups with computer-based randomization technique. All patients will have a fasting time of 2 hours for clear fluid and 6 hours for solid food. Patients will be taken to the premedication room before the operation. Written and verbal approval will be taken from all patients. Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer,every 15 minutes.Adult skin temperature probe will be used for continuous peripheral temperature measurement from four different body areas (T1:Cervical7 (C7) dermatome, T2:C6 dermatome T3:Lumbar 5( L5 )dermatome, T4: L4 dermatome). The two groups will have an infusion of balanced electrolyte solution with a rate of 8 Mililitre/Kilogram/ hour(mL/kg/hour). Patients in Group I will be covered with a 41 centigrade degrees double layered cotton clothes. Patients in Group II will receive active prewarming with a forced-air warming blanket (WarmCare full body blanket) 30 minutes prior to the operation. 0.1 mg/kg intravenous (iv) midazolam hydrochloride will be administered for premedication. Patients will be transferred to operating room, covered with warmed double layered cotton clothes. Standard monitoring (pulse oximetry, noninvasive blood pressure, electrocardiography) will be applied to the patients. Core temperature and 4-points skin temperature measurements will be recorded. Patients will be delivered 2 Liter/minute oxygen with a nasal cannula. Iv hydration will be continued by room temperature balanced electrolyte solution with an infusion rate of 2mililiter/kilogram/hour. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position. Then patients will be taken supine position. Hemodynamic measurements will be continued. Core temperature measurements will be done every 15 minutes. Peripheral skin temperature measurements will be continuous. 1st, 2nd ,3rd,4th ,5th ,6th, 7th, 8th, 9th and 10th minutes and every 5 minutes measurements will be recorded during the operation. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. The time for adequate sensorial block (T10) will be recorded. The patients will be repositioned (lithotomy) before the beginning of surgery. 5 mg iv ephedrine and 0.5 mg iv atropine will be administered when the blood pressure will be %80 of the baseline pressure and heart rate. Operating time, amount and temperature of irrigation fluids, transfusion requirement will be recorded. All patients will be transferred to post anesthesia care unit (PACU). Core temperature measurements will be continued every 15 minutes at PACU. Shivering scale and thermal comfort scale will be used during and after the operation. 25 mg iv meperidine will be administered when the patient's shivering score will be more than 3. Length of PACU stay will be recorded.

The study covers 2 groups. Group I will be covered with warmed double layered cotton cloth. Group II will be covered with air forced blanket.

Male patients scheduled for transurethral bladder resection

Effect of Prewarming On Skin Temperature Changes

Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder

F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe

S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe

T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe

T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe

T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe

M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe

centigrade degree , Timpanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,

centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,

thermal comfort will be rated on a 100mm visual analog scale (VAS),with zero indicating intense cold and 100mm representing intense heat

0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body

Bozyaka Training and Research Hospital

MD, Anesthesiology Resident

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Genital Diseases

Genital Diseases, Male

Urination Disorders

Lower Urinary Tract Symptoms

Urological Manifestations

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

After Subjects arrive at the MRI facility, subjects will fill out a medical questionnaire that will be used to determine whether a MRI study can be performed. The investigators will determine whether there are any problems that make the subject not suitable for participating in this study.

Thomas E Ahlering, MD

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand:

1. How effectively the tissues for continence and sexual function are cooled within the pelvis.
2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and
3. Determine if the endorectal balloon can be re-designed for improved QOL outcomes in men.

This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non-invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non-invasive technique, and answer formidable questions of the effectiveness of hypothermic cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

Prostate cancer is the second most frequent cause of cancer death in men and it accounts for 11% of all male cancers. Radical prostatectomy remains the gold standard for localized disease, offering the advantage of precise staging and grading and the real possibility of disease eradication. In the US there are approximately 100,000 radical prostatectomies (RP) performed for prostate cancer annually. However, there are two major challenges to the quality of life outcomes after radical prostatectomy: preserving urinary continence, and sexual function. The quality of life (QOL) after radical prostatectomy relies on the return of continence and sexual function after surgery to their pre-operative 'normal' status. The main factor which determines potency rates for patients is whether or not the nerves at the Neurovascular Bundles (NVB), are spared, and it may take years for sexual function to return. This may be due to the nerve injury from the nerve trauma in the surgical procedure. Similarly, a major factor involved in post-radical prostatectomy incontinence is preservation of the nerves that control the external urethral sphincter, bladder, and urogenital diaphragm. Also Inflammation from surgical removal of the prostate not only affects nerves, but also may directly damage the bladder, urethra, and pelvic floor. Effective strategies to prevent this damage are currently lacking. One stratagem to prevent or minimize such damage, is the use of local hypothermia with ice or cold irrigation around the nerves and tissues prior to, during, and after the injury has occurred. In numerous experimental models of central and peripheral nervous system injury, the use of moderate hypothermia (i.e. 28-33oC) has been shown to provide dramatic neuroprotection safely in humans, during cardiac, kidney, and brain surgery for many years.

MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

During pre and post hypothermia, initial temperatures will be measured simultaneously on five 3-mm-thick image slices that covered the target. The thermometry scan can be repeated every 6 s. Tissue temperature map is measured by magnetic resonance thermometry (echo planar imaging with multiphase; field of view: 25 × 25 cm; matrix 256 × 256; number of excitations: 1; repetition time: 545 ms; echo time: 20 ms; flip angle: 20°; slice thickness: 3 mm); (b) a thermal map of the tissue volume will be superimposed on the anatomical image.

Before the subject's scheduled radical prostatectomy surgery, they will have an MRI combined with an cooling endorectal balloon (this study), which will 1. Show the dimensions of their lower pelvis, including the prostate, and 2.Measure how cold the tissue around the prostate becomes using the cooling balloon. The thermal MRI images will allow elucidation of temperatures at specified anatomic locations and their changes over time. Data will be described using means for normally distributed continuous variables. We will test for associations between temperature and continence using t-tests to compare temperature change between those who achieve continence at 30 and 60 days and those who do not.

University of California, Irvine

Vice Chairman and Urology Professor

Kidney Neoplasms

Kidney Diseases

After arterial clamping, no ice slush will be used

After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes

Surround kidney in ice slush for 10 minutes after arterial clamping

Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation

A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Mayo Clinic

Bradley Leibovich

Thoracic Neoplasms

All patients needing pulmonary surgery under thoracotomy

Tympanic and oesophageal temperatures will be recorded during the procedure

Temperature recording

Francis REMERAND, MD-PHD

Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

The investigators therefore decided to evaluate the reliability of the oesophageal temperature in open chest lung surgery by comparing it to the continuous tympanic temperature.

Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery

Evaluate the correlation existing between the tympanic temperature, reflection of the central temperature without variation with an open thorax, and oesophageal temperature subject to changes.

University Hospital, Tours

Rare Diseases

Renal Insufficiency

Carcinoma, Renal Cell

Renal Cell Carcinoma

After clamping of the renal vessels, no ice slush will be used.

saline ice slush around kidney for 10 minutes.

Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.

When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery.

Renal hypothermia

Ilias Cagiannos, MD

The Objective is to determine if renal hypothermia during open partial nephrectomy results in improved post-operative renal function compared to warm ischemia.

Primary Aim is to determine the effect of hypothermia on preservation of overall renal function compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.

Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal function.

Secondary Aim is to determine the effect of hypothermia on preservation of affected renal function (kidney with the tumor) compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.

Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal function.

The incidence of renal cell carcinoma is increasing and in 2008 it is estimated that over 51,000 new renal cancers will be diagnosed in the United States. To preserve renal function, urologists commonly remove the diseased segment of the kidney (partial nephrectomy) instead of removing the entire kidney (radical nephrectomy). While the benefit of preserving function in patients with renal cell carcinoma has become clear, optimal preservation techniques are yet to be determined. Specifically, the role of hypothermia during partial nephrectomy has been inadequately studied despite theoretical benefit. The investigators objective is to assess the effectiveness of renal hypothermia during partial nephrectomy. The investigators hypothesis is that renal hypothermia during partial nephrectomy results in improved post-operative renal function compared to warm ischemia.

Methods: To test the investigators hypothesis, 180 partial nephrectomy patients will be randomized to cold or warm ischemia. Global and side-specific renal function will be assessed pre-operatively and 12 months post-operatively using radionucleotide clearance and renal scintigraphy.

Significance: To the investigators knowledge, this study will be the first prospective trial to evaluate the clinical impact of renal hypothermia during partial nephrectomy. Since renal function preservation is the primary purpose of partial nephrectomy, these findings will have an important impact on surgical technique and patient outcome.

Renal Hypothermia During Partial Nephrectomy

A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy

Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.

Side-specific renal function will be calculated by the product of overall glomerular filtration (determined from 99mTc-DTPA plasma clearance) and relative renal contribution (determined from 99mTc-DTPA renal scintigraphy).

Canadian Institutes of Health Research (CIHR)

Ottawa Hospital Research Institute

Other Dietary Supplements

Benzocaine

Tannic Acid

HumiGard device will be used to provide warmed humidified CO2 for insufflation during laparoscopic surgery. The device will be used alongside standard methods of keeping the patient warm in theatre. The theatre team will monitor the patient's temperature at regular time points before, during and after surgery. Warmed fluids, forced air warming devices or warmed blankets will be used as required to maintain normothermia.

Patients will receive standard methods of keeping the patient warm in theatre. The theatre team will monitor the patient's temperature at regular time points before, during and after surgery. Warmed fluids, forced air warming devices or warmed blankets will be used as required to maintain normothermia.

A sham HumiGard device will be used in the standard care arm. This will be the same HumiGard device as is in the intervention arm. However, the sham device will be turned "off" so that the gas delivered to the peritoneal cavity for insufflation is not heated or humidified. The sham device will deliver CO2 (as is the case for current standard practice in the hospital) through the HumiGard tubing. The sham device will look and sound the same as the active intervention arm where the HumiGard device is switched "on" and is delivering warm, humidified CO2 to the peritoneal cavity.

HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery

HumiGard device

Standard methods of keeping the patient warm whilst in theatre, including warmed IV fluids, warming blankets/forced air warming devices.

Standard care (with sham HumiGard device)

Nicola Reeves, MD

During long surgical procedures under general anaesthetic, patients' body temperatures sometimes drop below 36°C. This is classified as hypothermia. These low temperatures are associated with medical complications and surgical wound infections. Despite various warming methods used during surgery a significant number of patients experience hypothermia during surgery. During laparoscopic procedures, standard practice is to use dry, unwarmed carbon dioxide (CO2) to inflate the peritoneum (insufflation). This may contribute to the risk of hypothermia and cause tissue desiccation.

HumiGard is a CE marked device which humidifies and heats CO2 for insufflation. It is used together with other standard methods of keeping patients warm. Other studies suggest that the HumiGard device may prevent hypothermia, and help patients recover more quickly and with fewer problems after surgery.

The investigators aim to find out whether the HumiGard device used with standard practice, gives better outcomes for patients, compared to standard care alone. To do this, the investigators first need to work out if such a study would be feasible to do and therefore whether a larger study can be done.

A total of 40 patients who are having a laparoscopic colectomy operation (where a portion of their bowel is removed) will be recruited. Half will be treated with the HumiGard device plus standard care and half will be treated with a sham HumiGard device plus standard care. Patients will be allocated to one of these groups by random chance. Neither the patient, the surgeon, nor the assessor will know which treatment the patient is having.

The investigators will measure patients' temperature during surgery, and also patients will be asked to complete a validated questionnaire to measure their quality of recovery and pain following surgery. The feasibility study will aim to highlight the most appropriate outcomes to be measured in a larger RCT.

Laparoscopic surgery involves filling the peritoneal cavity with carbon dioxide (CO2) gas (insufflation) to increase the working and viewing space in the abdomen. It is standard care in the United Kingdom (UK) to use dry, unwarmed CO2. There is evidence that dry, unwarmed insufflation is associated with tissue desiccation and intraoperative hypothermia showing that insufflation of cool dry gas resulted in a temperature drop of 1.3-1.7°C. Despite active warming methods, perioperative hypothermia is common. One study demonstrated that nearly half of patients had continuous core temperatures of 36°C for more than an hour.

HumiGard (Fisher and Paykel Healthcare) is a CE marked medical device designed to humidify and heat CO2 for insufflation. A meta-analysis included 13 studies (total of 796 patients) comparing warmed, humidified CO2 insufflation compared to unwarmed, dry CO2 in patients having a range of procedures. There was a significant difference in mean core temperature change, and an effect size of +0.3°C (95% confidence interval \[CI\]: 0.1-0.6). This was more pronounced in studies of long procedures (80 min). Another meta-analysis of 15 studies (1026 patients) demonstrated a small beneficial effect on immediate post-operative pain but not at day 1 or 2. Warmed, humidified CO2 reduced the risk of intraoperative hypothermia (p=0.004) but postoperative core temperatures were not significantly different (10 studies, 718 patients). No differences were observed in analgesic consumption, length of stay, or procedure duration.

This is a blinded, randomised controlled feasibility study on 40 patients receiving laparoscopic colorectal resectional surgery at a single site (University Hospital of Wales) and treated with either the HumiGard device plus standard care (20 patients) or a sham HumiGard device plus standard care (20 patients).

This study will assess various aspects of a proposed larger pragmatic blinded, RCT evaluating whether HumiGard insufflation device, when used with standard care, can improve patients' quality of recovery after laparoscopic colectomy surgery.

The feasibility study will aim to highlight the most appropriate outcomes to be measured in a main RCT, particularly looking at the role of Quality of Recovery (QoR-40) questionnaire or continuous temperature measurements. The investigators will assess whether the outcomes of the study are suitable, achievable and measurable. The study will assess recruitment, ability to blind operating surgeon with a sham HumiGard device, use of urinary temperature probe compared to standard temperature monitoring in theatre, use of QoR-40 and visual analogue score (VAS) pain score by patients preoperatively (for a baseline score) and on post-operative day (POD) 1, 3 and 30, analgesia use, and intraoperative patient warming techniques. Length of stay in hospital from procedure to discharge (or until medically fit for discharge) will also be recorded and reported.

Furthermore, methods for analysing the postoperative complication rate will be evaluated. Complications will be recorded at POD1, POD3, upon discharge and POD30. Their severity will be graded using the Clavien-Dindo scale, a widely used and valid method for grading severity of surgical complications which helps to reduce subjectivity. The Comprehensive Complication Index (CCI) will then be used to create a composite score (0-100) for each patient.

Feasibility study - 40 patients to be randomised 1:1 to two groups - 50% receiving HumiGard and 50% receiving standard care alone

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Prewarming On Skin Temperature Changes	NCT05063292	Spinal Anesthes... Hypothermia Fol... Prewarming Core Temperatur... Urological Canc...	Patients in Gro...	50 Years - 80 Years	Bozyaka Training and Research Hospital
MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon	NCT01979848	Prostate Cancer Hypothermia Urinary Inconti... Erectile Dysfun...		21 Years -	University of California, Irvine
A Pilot Study of Renal Hypothermia During Partial Nephrectomy	NCT00888641	Kidney Neoplasm	Hypothermia	18 Years -	Mayo Clinic
Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery	NCT03903991	Hypothermia Thoracic Neopla... Anesthesia	Temperature rec...	18 Years -	University Hospital, Tours
Effect of Prewarming On Skin Temperature Changes	NCT05063292	Spinal Anesthes... Hypothermia Fol... Prewarming Core Temperatur... Urological Canc...	Patients in Gro...	50 Years - 80 Years	Bozyaka Training and Research Hospital
Renal Hypothermia During Partial Nephrectomy	NCT01529658	Renal Impairmen... Kidney Diseases Urologic Diseas... Cancer Hypothermia Kidney Cancer	Renal hypotherm...	18 Years -	Ottawa Hospital Research Institute
HEAT HumiGard Evaluation Study	NCT04164706	Laparoscopic Co...	HumiGard device Standard care (...	18 Years -	Cardiff and Vale University Health Board
Use of Hypothermia During Robotic Prostatectomy	NCT00915031	Prostate Cancer	UroCool	18 Years -	University of California, Irvine
HEAT HumiGard Evaluation Study	NCT04164706	Laparoscopic Co...	HumiGard device Standard care (...	18 Years -	Cardiff and Vale University Health Board
Renal Hypothermia During Partial Nephrectomy	NCT01529658	Renal Impairmen... Kidney Diseases Urologic Diseas... Cancer Hypothermia Kidney Cancer	Renal hypotherm...	18 Years -	Ottawa Hospital Research Institute
Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival	NCT06256354	Hypothermia Delirium Long-term Survi... Cancer Surgery	Routine thermal... Target temperat...	65 Years -	Peking University First Hospital

Spots Global Cancer Trial Database for hypothermia

Every month we try and update this database with for hypothermia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hypothermia

Every month we try and update this database with for hypothermia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hypothermia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.