This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Large Scale Cerebral Oximetry During Sinus Endoscopy

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Icahn School of Medicine at Mount Sinai
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02692794
First received: February 23, 2016
Last updated: November 21, 2016
Last verified: November 2016
  Purpose
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.

Condition
Endoscopic Sinus Surgery Chronic Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Large Scale Cerebral Oximetry During Sinus Endoscopy

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Post-operative Quality of Recovery Scale [ Time Frame: Day 1- 1 hour post-operatively ]
    Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery

  • Post-operative Quality of Recovery Scale [ Time Frame: Day 2 ]
    Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery


Secondary Outcome Measures:
  • Incidence of nausea/vomiting [ Time Frame: Day 1 - 1 hour post-operatively ]
    Increased incidence of nausea/vomiting post-operatively in patients with cerebral desaturation during the course of sinus surgery


Other Outcome Measures:
  • Incidence of pain experience [ Time Frame: Day 1 - 1 hour post-operatively ]
    Incidence of post-operative pain experienced in patients with cerebral desaturation during the course of sinus surgery


Biospecimen Retention:   None Retained
Specify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue)

Estimated Enrollment: 100
Study Start Date: October 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Research Plan

This study will be conducted at Mount Sinai Hospital. Patients will be recruited by reading the operating room schedule in advance and contacting patients over the phone to explain the study, risks and benefits, and obtain informed consent prior to admission to the hospital.

Objective 1 The specific aim of this observational study is to evaluate changes in cerebral tissue oxygen saturation in patients undergoing head and neck surgery under general anesthesia with mechanical ventilation using the Casmed Foresight cerebral oximeter.

Ensuring patient safety in surgeries upon the head and neck is a complex task in anesthesiology. These patients present a myriad of concerns that need to be considered to create a safe and thorough anesthetic plan that include potentially difficult airways, varied patient positioning, and the intricate involvement of anesthetic drugs upon the quality of the surgical field. During common procedures such as sinus endoscopy, patients undergo endotracheal intubation and mechanical ventilation for airway protection and a strategy of deliberate hypotension is implemented with the goal of creating a clean surgical field that minimizes avoidable bleeding. The objective of this strategy is to allow the surgeons to complete their procedure more quickly and with less hypothetical risk of injury due to poor visualization of structures. However, this strategy of deliberate hypotension carries with it the potential risk of cerebral hypoperfusion as the lower limits of cerebral autoregulation are not known on an individual patient basis. Furthermore, mechanical ventilation- particularly with hyperventilation- can further decrease cerebral blood flow and potentially compromise cerebral perfusion. The current standard of care to monitor the hemodynamics of patients undergoing these procedures are standard American Society of Anesthesiologists monitors, which includes non-invasive blood pressure measurements. The investigators propose the use of a non-invasive monitor of cerebral oxygenation with cerebral oximeter probes in a prospective, observational study of a series of patients undergoing routine head and neck surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing primary or revision endoscopic sinus surgery for chronic rhinosinusitis
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02692794

Contacts
Contact: Mohemmed Khan, MD 201-707-2016 mohemmed.khan@mountsinai.org
Contact: Satish Govindaraj, MD 212-241-9410 satish.govindaraj@mountsinai.org

Locations
United States, New York
Icahn School of Medicine Recruiting
New York,, New York, United States, 10029
Principal Investigator: Satish Govindaraj, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Satish Govindaraj, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02692794     History of Changes
Other Study ID Numbers: GCO 15-1192
Study First Received: February 23, 2016
Last Updated: November 21, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
sinusitis
oximetry
paranasal sinus diseases

ClinicalTrials.gov processed this record on July 21, 2017