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NCT02692794 · ClinicalTrials.gov registry record
Large Scale Cerebral Oximetry During Sinus Endoscopy
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 100
- Enrollment target
NCT02692794: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02692794 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02692794 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-06-20 |
What the finished NCT02692794 record still lists
NCT02692794 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02692794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02692794 about?
NCT02692794 is a clinical study titled "Large Scale Cerebral Oximetry During Sinus Endoscopy". 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 ma...
What is the current status of trial NCT02692794?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2015-10. Estimated completion is 2016-06-20.
Who is sponsoring clinical trial NCT02692794?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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