Large Scale Cerebral Oximetry During Sinus Endoscopy

NCT02692794 | Completed DMC

• 1 other identifier: GCO 15-1192
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endoscopic Sinus Surgery; Chronic Rhinosinusitis

Keywords

sinusitis; oximetry; paranasal sinus diseases

Outcome Measures

Primary Outcomes (2)

• Post-operative Quality of Recovery Scale

  Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery

  Day 1- 1 hour post-operatively

• Post-operative Quality of Recovery Scale

  Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery

  Day 2

Secondary Outcomes (1)

• Incidence of nausea/vomiting

  Day 1 - 1 hour post-operatively

Other Outcomes (1)

• Incidence of pain experience

  Day 1 - 1 hour post-operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary or revision endoscopic sinus surgery for chronic rhinosinusitis

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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine

New York, New York, 10029, United States

Location

Biospecimen

Retention: NONE RETAINED

Specify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue)

MeSH Terms

Conditions

Sinusitis; Paranasal Sinus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Satish Govindaraj, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: October 1, 2015
• Primary Completion: June 20, 2016
• Study Completion: June 20, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)