Large Scale Cerebral Oximetry During Sinus Endoscopy

Completed

Conditions studied: Endoscopic Sinus Surgery, Chronic Rhinosinusitis

In brief

Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding. These methods reduce blood flow to the head and neck area and assist in reducing bleeding during surgery but they may predispose patients to cerebral ischemia. Large scale studies necessary to conduct adequate statistical analysis regarding the effect of cerebral oximetry on otolaryngology surgery has not been extensively studied. This study seek to address the question of whether cerebral oximetry in the FESS population can help evaluate major and minor post operative morbidity, as well as the quality of recovery from surgery. Cerebral oximeters are small, noninvasive stickers applied to the forehead of participants and give the examiners data regarding the level of oxygen saturation around the brain during the course of surgery. During the course of such procedures, where blood flow to the head and neck area is intentionally decreased to assist in reducing bleeding during surgery, the levels of oxygen saturation around the brain may pose as a predictor or major and minor post operative morbidity, as well as the quality of recovery from surgery. Outcome measures will include major post operative complications, such as neurological and cardiac complications, and minor post operative morbidity, such as length of post anesthesia care unit (PACU) length of stay, nausea, and vomiting. Quality of recovery will also be assessed using a survey conducted in the PACU and again at the first post operative visit approximately one week after surgery.

Key facts

Study ID

NCT02692794

Run by

Icahn School of Medicine at Mount Sinai

People needed

100

Starts

2015-10-01

Expected to finish

2016-06-20

Last updated by the study team

2017-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• patients undergoing elective head and neck surgery at Mount Sinai Hospital in which 1) the patient will be intubated and mechanically ventilated, with 2) head of bed elevated, and in which 3) an anesthesiologist could consider deliberate hypotension as part of their management

You may not qualify if…

• patients under 18 years old
• patients who are currently prisoners
• patients who do not appear to have capacity to consent to the study
• patients who cannot provide informed consent in English
• pregnant women
• patients who decline to participate in the study.

Where it is running

• Icahn School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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