Nervous System Diseases

Heart and Blood Diseases

All Conditions

Neoplasms

Stroke

Head and Neck Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Vasoconstrictor Agents

Other Dietary Supplements

Anesthetics

Benzocaine

Tannic Acid

Arterial line (radial, femoral, dorsalis pedis, or brachial), central line for access when needed, intubation vs tracheostomy, general anesthesia. We currently use stroke-volume variability monitoring (FloTrac) in all patients using the arterial line placed for blood pressure monitoring.

The study will use a treatment algorithm for patients in the treatment group. This algorithm will aim to maintain a near-normal blood pressure and use goal directed therapy to achieve this. Currently the standard of care is to use IV fluid exclusively in these patients and anesthesia providers everywhere have been challenging that treatment plan. Our algorithm has an iterative approach assessing volume status, cardiac output and vascular tone in order, with interventions specified for each. Individual treatments have been proven safe and effective in this population, we believe this sequence may be the best current management system. By avoiding excessive fluid administration we expect to decrease ICU length of stay due to the comorbidities caused (pulmonary edema, bowl edema, glycocalyx damage).

FloTrac

Scott T Reeves, MD

This study aims to investigate whether the intraoperative use of the FloTrac device to guide fluid and vasopressor management during head and neck free flap surgery improves postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary postoperative outcomes include days in ICU, days on ventilator, presence of postoperative pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap complication rate, inpatient postoperative cardiorespiratory complications/events, and overall 30 day flap failure rate.

Few animal models have shown that intravenous vasopressor administration (including use of pure alpha agonists such as phenylephrine) can decrease blood flow to free musculocutaneous flaps (1-3). This has led to a dogmatic belief that all vasopressors should be avoided intraoperatively during a microvascular free flap reconstruction regardless of patient hemodynamics, even though there is little published evidence that pressors negatively affect free flap outcome (4). As a result, these patients often receive generous amounts of fluids during their intraoperative course to combat periods of hypotension. However, patients receiving head and neck free tissue transfers tend to be older with serious comorbidities related to long term tobacco use such as significant cardiovascular and pulmonary disease. Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that may not necessarily be related to hypovolemia. Consistently treating periods of hypotension with more intravenous fluids can lead to serious postoperative complications such as graft failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a retrospective review of 248 patients over a 34 month period that received a head and neck free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid administration significantly increased 30 day flap complication rate while intraoperative administration of vasopressors did not affect 30 day flap complication or 30 day failure rate.

The FloTrac device is an approved and validated medical device that analyzes the arterial pressure waveform to calculate a stroke volume variation. This stroke volume variation can be used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor management during periods of intraoperative hypotension (5). The use of the FloTrac device for goal directed therapy has been investigated in major abdominal surgery and found to decrease length of hospital stay and complication rate in this surgical population (5-6). Thus, it is possible that the intraoperative use of the FloTrac device can better guide anesthesia providers to provide the necessary therapy for intraoperative hypotension in patients undergoing head and neck freet tissue transfer, thus improving postoperative outcome.

A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps

Does the Intraoperative Use of the FloTrac Device to Guide Fluid and Vasopressor Management Affect Postoperative Morbidity in Patients Receiving a Head and Neck Microvascular Free Tissue Transfer

The primary outcome is length of ICU stay.

The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator

Medical University of South Carolina

FloTrac device was used to manage blood pressure during surgery.

Treatment Group

FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.

Control Group

Total

Age, Continuous

Sex: Female, Male

Dr Hand

ICU Stay

Number of Participants Requiring a Ventilator

Overall Study

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Postoperative Complications

Esophageal Cancer

Respiratory System Agents

Cardiotonic Agents

Norepinephrine

Oxymetazoline

Phenylephrine

Dobutamine

Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

1. Crystalloid infusion (2,5 ml/kg/t) throughout surgery
2. 3 ml/kg Volulyte (synthetic colloid) is infused during 5 minutes and SV is measured directly before and 5 minutes after. If SV increases more than 10% the dose is repeated until no increase \> 10% is observed. A new dose is given if SV decreases more than 10% from the last value.
3. If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI \> 2,5.
4. If despite CI \> 2,5 Mean Arterial Pressure \<65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65.

fluid optimisation

Lena Nilsson, MD PhD

Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).

Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection

Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps	NCT02186938	Head and Neck C... Patients Requir...	FloTrac	18 Years -	Medical University of South Carolina
A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps	NCT02186938	Head and Neck C... Patients Requir...	FloTrac	18 Years -	Medical University of South Carolina
Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection	NCT01416077	Esophageal Canc...	fluid optimisat...	18 Years -	University Hospital, Linkoeping

Spots Global Cancer Trial Database for flotrac

Every month we try and update this database with for flotrac 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 flotrac

Every month we try and update this database with for flotrac 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 flotrac 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.