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After end of surgery, hyperventilation and administration of a small, precalculated amount of CO2 into the breathing circuit will be performed.

After end of surgery, patients will be subdued to a standard weaning procedure.

Mechanical hyperventilation to enhance elimination of inahalation anesthetics. Administration of a precalculated flow of CO2 according to gender and weight into the inspiratory limb of the breathing circuit in order to avoid hypocapnia.

Isocapnic hyperventilation

Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery, the investigators evaluated the feasibility of an alternative technique of IHV. By performing a prospective, randomised controlled study, the investigators want to further test this alternative method for IHV.

Isocapnic hyperventilation (IHV) provides an alternative method for weaning from inhalation anaesthesia which decreases the time to eye-opening, extubation and time spent in the PACU. The method is well known since at least 40-50 years and involves the maintenance of a stable CO2 level during hyperventilation, which increases the elimination of anaesthetic gas without producing hypocapnia. Studies have declared that the reduction in time to eye-opening is 50-60 % compared to a standard weaning procedure after inhalation anaesthesia.

There are several principally different ways to maintain the CO2 level during hyperventilation, where a number of technical solutions that add dead-space to the anaesthesia circuit and thereby produce rebreathing of CO2 during hyperventilation are the most studied methods so far. However, the original method of directly adding CO2 to the breathing circuit during hyperventilation could be considered in need of a re-evaluation, as modern anaesthesia delivery units and monitoring equipment to a great extent can eliminate the risk of hypercapnia, that was described with this procedure in the 1980ies.

An alternative IHV method is to directly infuse CO2 to the inspiratory limb of the breathing circuit through a mixing box while using mechanical hyperventilation by a standardised protocol. This technique was recently evaluated by the investigators, in a bench test, and in an in vivo model. Based on these studies, the CO2 dosage needed to achieve isocapnia during HV at various levels of alveolar ventilation, CO2 production and dead space was estimated and a gender- and weight-based nomogram for CO2 delivery during IHV was constructed. Furthermore, the investigators could show, in vivo, that the washout time of sevoflurane anaesthesia was one-third compared to normal ventilation. The feasibility of this IHV method was evaluated in a pilot study in humans, based on the results of our two previous experimental studies. To finalize the project the investigators now conduct a prospective randomized trial to evaluate the efficacy of the method, compared to a standard weaning procedure, after long-term sevoflurane anaesthesia.

Isocapnic Hyperventilation - an Alternative Method

Isocapnic Hyperventilation for Enhancing Recovery After Inhalation Anaesthesia - an Alternative Method

Postoperative quality of recovery (PQRS) scale

Sahlgrenska University Hospital, Sweden

Consultant

Nervous System Diseases

Rare Diseases

Infratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Oculocerebral Syndrome With Hypopigmentation

• Group 1: hyperventilation (ETco2 25-30 mm Hg) for 20 minutes that will start immediately after skin incision followed by normoventilation (ETco2 31-35 mm Hg) for another 20 minutes.

• Group 2: normoventilation (ETco2 31-35 mm Hg) for 20 minutes immediately after skin incision followed by hyperventilation (ETco2 25-30 mm Hg) for another 20 minutes.

evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.

cerebral oximetry

The aim of this study is to evaluate the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.

Introduction:

Hyperventilation has been used for intraoperative brain relaxation for decades, Interestingly, this common practice is not based on robust evidence .

The mechanism of brain relaxation secondary to hyperventilation is attributed to the hypocapnia induced cerebral vasoconstriction and the subsequent reduction of cerebral blood volume (CBV) and intracranial volume. The CBV reduction is accompanied by the reduction in cerebral blood flow that could render the brain at ischemic risk, if the cerebral metabolic activity remains the same before and after hyperventilation. So, it is possible that inadvertent cerebral ischemia may outweigh the benefits of hyperventilation and should be subjected for further investigation.

Cerebral near-infrared spectroscopy (NIRS) is a useful non-invasive tool for regional cerebral oxygen saturation (rScO2) monitoring, which provides continuous, real time information on the balance between cerebral oxygen delivery and consumption.

Cerebral oximetry monitoring had the ability to detect clinically silent episodes of cerebral ischemia in a variety of clinical settings which could be an important safeguard for cerebral function.

Hyperventilation had been shown to significantly reduce cerebral oxygenation using near-infrared spectroscopy in patients undergoing elective abdominal surgery.

Multiple studies have shown that prolonged hyperventilation correlated with poor outcome especially in brain injured patients. 5,6 However, there is still a lack of evidence on the relationship between hyperventilation and neurological outcome in patients having craniotomy.

However, to the best of the investigator's knowledge no previous randomized controlled trials had studied the effect of hyperventilation versus normo-ventilation on cerebral oximetry in pediatrics undergoing posterior fossa tumor surgeries.

V. Study procedure:

This is a prospective, randomized controlled trial with a two-period crossover design so that the patient can act as a control to himself. Enrolled patients are children (1-6 years old) undergoing posterior fossa tumor resection. Prior to anesthetic induction, the two sensors (SAFB-SM, Covidien, Dublin, Ireland) for near-infrared spectroscopy (INVOS 5100C, Covidien, Dublin, Ireland) will be applied on the left and right sides of the forehead with the caudal border approximately 1 cm above the eyebrows to measure regional oxygen saturation (rSO2). A bispectral index (BIS) sensor will also be fixed on the left forehead (Model QUATRO, Covidien, Dublin, Ireland) to monitor the depth of anesthesia. Both sensors will be fixed to their positions using adhesive pads to avoid removal during positioning and soaking with betadine solution. Baseline values for cerebral oxygen saturation will be obtained using NIRS monitor, Standard monitors (electrocardiogram, non-invasive blood pressure, pulse oximeter) will be applied to all patients. The anesthetic management will be standardized for all patients as follows:

General anesthesia will be induced by inhalational agent 'sevoflurane' until intravenous line is secured then Fentanyl (1-2 µg/kg), Propofol (1-2 mg/Kg) will be given intravenously. Intubation will be facilitated by Atracurium (0.5 mg/kg) and confirmed by capnography. Nasopharyngeal temperature probe will be inserted for monitoring of core body temperature which will be kept between 36.5-37 C using warming blankets. A 22 G arterial cannula will be placed in the left radial artery and baseline ABG will be obtained to correlate value of Etco2 and Paco2. Anesthesia will be maintained with isoflurane in oxygen 40% and will be adjusted to maintain BIS between 40 and 60 and Atracurium infusion (0.5 mg/kg/hr). Central venous line will be inserted in the right internal jugular vein under complete aseptic condition under ultrasound guidance, wide bore peripheral cannula will be inserted for fluid management and a Foley's catheter will be inserted in the urinary bladder for urine output monitoring. Patients will be positioned in the prone position with the arms positioned and secured at the patient's side and after careful padding of the pressure points; the patient head will be supported on the forehead using a horseshoe adapter. Slight neck flection will be permitted till the anesthetist can pass two fingers easily between the chin and the chest to allow for optimum surgical exposure. Patients will be randomly assigned using concealed envelopes, according to a computer-generated random number to one of the following two treatment sequences:

* Group 1: hyperventilation (ETco2 25-30 mm Hg) for 20 minutes that will start immediately after skin incision followed by normoventilation (ETco2 31-35 mm Hg) for another 20 minutes.
* Group 2: normoventilation (ETco2 31-35 mm Hg) for 20 minutes immediately after skin incision followed by hyperventilation (ETco2 25-30 mm Hg) for another 20 minutes. The ventilation strategies will be achieved using volume-controlled mode with a tidal volume of 8 ml/kg, I/E ratio:1/2 and ETco2 will be maintained at the desired range by adjusting the respiratory rate. Positive end-expiratory pressure (PEEP) will not be applied. After removal of the bone flap and exposure of the dura matter, a 20-gauge plastic cannula will be inserted into the subdural space along the surface of the brain. This will be connected to a calibrated pressure transducer via a length of polyethylene high pressure tubing filled with normal saline. The transducer will be zeroed at ear level. During the study period, the mean subdural pressure will be recorded at 2 minutes intervals at the end expiratory phase.

Assessment phase 1: An arterial blood sample will be obtained immediately after skin incision for blood gas analysis to determine the difference between arterial and end-tidal carbon dioxide tension (Pa-ETCO2). Ventilation and ETCO2 will be kept constant for at least 20 min, which is long enough for stabilization of any vascular responses to the change in Paco2. At the end of the equilibration period (20 minutes), another arterial blood sample will be obtained to confirm that the targeted Paco2 (was achieved. The neurosurgeon, unaware of the anesthetic and ventilatory management provided, will be then asked to score the brain bulk according to a four-point scale as follows:

1. Excellent with no swelling
2. Minimal swelling, acceptable
3. Swollen but no treatment required
4. Swollen, needing treatment. After this assessment, ventilation will be changed immediately according to group assignment.

Assessment phase 2: Another 20 min of equilibration will be allowed and measurements will be repeated as previously described. During the whole period of study (40 minutes), the cerebral oximetry will be recorded at 5 minutes intervals. During this period factors that may affect cerebral oximeter will be controlled by maintaining position of the patient head, (normothermia with temperature at 36.5-37 C), within 20% of the base line blood pressure using increments of ringer solution and ephedrine boluses as appropriate, maintain PH 7.35-7.45, Hb level around 10 gm/dl guided by blood loss and repeated measurements of Hb in ABG and blood glucose level between 80-180 mg/dl. The study will be ended at this point, the subdural cannula will be removed, and surgery will proceed as normal. Specific or routine interventions for brain swelling such as a change in body position or diuretic therapy with mannitol or furosemide will not be administered until the study had ended. However, for ethical reasons, interventions will be made if requested by the surgeon and the patient will be then withdrawn from the study. Data will be collected by an independent blinded anesthesiologist using a data collection form.

• Measurement tools:

* Demographic and categorical characteristics including patient's age in years, weight in Kg, gender, type of the procedure( 4th ventricular, medulloblastoma,... )
* Both NIRS values at baseline and every 5 minutes during each phase of the study
* Subdural intracranial pressure (ICP) every 2 minutes during each phase of the study
* End tidal co2 every 5 minutes during each phase of the study
* Paco2 baseline and at the end of each phase of ventilation (20 minutes following start of phase 1 assessment and 20 minutes after start of phase 2 assessment)
* Heart rate and mean arterial blood pressure every 10 minutes.
* Brain relaxation score

The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery

The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery: Randomized Controlled Cross Over Study

NIRS value at the end of phase 1 assessment in each group

Brain relaxation score: four-point scale as follows:

1. Excellent with no swelling
2. Minimal swelling, acceptable
3. Swollen but no treatment required
4. Swollen, needing treatment. the higher the score the higher the intracranial pressure

Kasr El Aini Hospital

lecturer of anesthesia

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Cognitive behavioural therapy + Standard Medical Care (cognitive-behavioural therapy+SMC):

8 hour-long manual-based CBT sessions with a therapist, weekly or fortnightly.

Participants assigned to the SMC group (i.e., control group) will receive all the treatment and support they would otherwise receive outside of a research trial.

Behavioral: Cognitive behavioural therapy (CBT) The CBT intervention used in the trial has been adapted for people with PPS and it is based on a model of understanding PPS (Deary et al 2007). The therapy aims to help the patient develop an understanding of the relationship between cognitive, physiological and behavioural aspects of their problem; to understand factors that may be maintaining the problem and to learn how to modify their behavioural and cognitive responses in order to improve quality of life. The approach is transdiagnostic in that it targets processes and underlying mechanisms that affect disorders similarly, rather than focusing on how they are diagnostically different. The approach is personalised during therapy following a detailed assessment.

Cognitive behavioural therapy (CBT)

Trudie Chalder, PhD

Brief Summary: Persistent Physical Symptoms (PPS), also known as medically unexplained symptoms (MUS) is a term used to describe a range of persistent bodily symptoms for which the exact cause is unclear. Between 20 and 40% of patients in primary care, and about 50% in secondary care experience PPS. Not only are PPS common, but the overlap across different patient groups may indicate that these phenomena are transdiagnostic. PPS are associated with profound disability and high health care costs, and if left untreated the prognosis of these patients is poor. There is an accumulating body of evidence demonstrating that cognitive behavioural interventions can reduce levels of symptoms and improve functioning in patients with PPS. A pragmatic randomised controlled trial (RCT) was designed to evaluate the clinical and cost-effectiveness of cognitive behavioural therapy (CBT) + Standard Medical Care (SMC) versus Standard Medical Care alone, in the treatment of patients with PPS. The trial will focus on patients with a variety of symptoms (e.g., non-cardiac chest pain, fibromyalgia), across secondary care clinics (e.g., neurology, cardiology, and rheumatology).

Background and study aims In primary care between 20 and 40% of patients have medically unexplained physical symptoms. The term medically unexplained symptoms (MUS) is commonly used by health care professionals. However a survey of a healthy population and a separate survey of patients with chronic fatigue syndrome (CFS) suggested that the term persistent physical symptoms (PPS) was the preferred term. The term PPS may have its drawbacks, but it will be used in the rest of this document to cover MUS as well as any other terms that may be used in the literature and clinical settings to refer to these symptoms. In secondary care, about 50% of patients have PPS, in many specialties. PPS are associated with profound disability and high health care costs. Around 50% of sufferers have co-morbid anxiety and depression and sleep problems. Left untreated, the prognosis of these patients is poor.

This study is a pragmatic RCT that will evaluate the clinical and cost-effectiveness of cognitive behavioural therapy + standard medical care (CBT+SMC), which involves 8 sessions of CBT, versus standard medical care (SMC) in the treatment of patients with PPS.

Who can participate? Patients with various PPS, such as fibromyalgia, non-cardiac chest pain, irritable bowel syndrome and a range of neurological symptoms e.g., weakness will be recruited. Participants will be recruited from clinics in secondary care (e.g., neurology, cardiology, rheumatology) at various hospitals in London.

What does the study involve? Potential participants will be identified by clinical staff who will refer them to the research team. Patients who give their consent to take part in the study will complete a number of questionnaires asking about their symptoms and use of health care services, and about their thoughts, feelings, and beliefs related to their PPS (i.e., baseline). This will take approximately 1.5 hours. After this research assessment, half of participants will be randomly assigned to the treatment arm (CBT+SMC), or to the control (SMC) arm. Participants in the treatment arm will receive 8 individual sessions of CBT (weekly or fortnightly sessions). The therapy aims to help the patient develop an understanding of the relationship between cognitive, physiological and behavioural aspects of their problem; to understand factors that may be maintaining the problem and to learn how to modify their behavioural and cognitive responses in order to improve their quality of life. Participants in the SMC group will receive usual medical care within the clinic.

Participants in both arms will also be asked to complete questionnaires at 9, 20, 40, and 52 weeks after randomisation. The assessment will be independent of the health care professionals delivering care.

What are the possible benefits and risks of participating? By taking part in the study patients may get helpful information about their condition. If assigned to the CBT+SMC arm, patients will receive 8 sessions of CBT focused on helping them manage their symptoms, which may improve their symptoms and increase their psychosocial functioning. It is unclear whether CBT for patients with PPS is effective; this trial will assess whether there are benefits to receiving it. Patients may benefit from being followed up closely and completing measures. It is not expected that participation in the study is associated with risks. The therapists involved in the trial are highly qualified specialists with extensive experience in treating patients with PPS. The trial team also includes a psychiatrist who will further ensure patient safety in complex cases. Participants will be free to take a break at any point during the meetings and are free to withdraw from the study at any point. Participants will also be informed that they can raise any concerns they may have with the research team and will be provided with the Patient Advice \& Liaison Service contact information.

Where is the study run from? The study has been set up by the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King's College London and the South London and Maudsley National Health Service (NHS) Foundation Trust, and will be conducted at several hospitals in London/Greater London, including Guy's and St Thomas' Hospitals, King's College Hospital, Princess Royal University Hospital, Royal Free Hospital, University Hospital Lewisham and Queen Elizabeth Hospital.

When is the study starting and how long is it expected to run for? The study has started in July 2015 and the end date for the project is March 2019.

Who is funding the study? The study is funded by the Guy's and St. Thomas' Charity.

Who is the main contact? Prof Trudie Chalder trudie.chalder@kcl.ac.uk

CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE)

The PRINCE Secondary Study: Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Secondary Care

Measures improvement of patient-defined self-rated problems

Measures severity, distress, interference and problematic nature of PPS

Measures patient's perception of their general health improvement

Measures health care service receipt, direct and indirect costs of illness, and cost-effectiveness of interventions

assesses degree of acceptance of difficult symptoms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Isocapnic Hyperventilation - an Alternative Method	NCT03074110	Oropharyngeal N...	Isocapnic hyper...	18 Years -	Sahlgrenska University Hospital, Sweden
The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery	NCT04232059	Infratentorial ... Hyperventilatio... Craniotomy	cerebral oximet...	1 Year - 6 Years	Kasr El Aini Hospital
The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery	NCT04232059	Infratentorial ... Hyperventilatio... Craniotomy	cerebral oximet...	1 Year - 6 Years	Kasr El Aini Hospital
CBT Plus SMC Compared to SMC for Persistent Physical Symptoms in Secondary Care (PRINCE)	NCT02426788	Persistent Phys...	Cognitive behav...	18 Years - 70 Years	King's College London

Spots Global Cancer Trial Database for hyperventilation