Large Scale Cerebral Oximetry During Sinus Endoscopy
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|ClinicalTrials.gov Identifier: NCT02692794|
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : August 10, 2017
|Condition or disease|
|Endoscopic Sinus Surgery Chronic Rhinosinusitis|
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.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Large Scale Cerebral Oximetry During Sinus Endoscopy|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||June 20, 2016|
|Actual Study Completion Date :||June 20, 2016|
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692794
|United States, New York|
|Icahn School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Satish Govindaraj, MD||Icahn School of Medicine at Mount Sinai|