Skip to main content
Clinical Trials/NCT01546636
NCT01546636
Completed
Not Applicable

The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

NorthShore University HealthSystem1 site in 1 country70 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Ischemia
Sponsor
NorthShore University HealthSystem
Enrollment
70
Locations
1
Primary Endpoint
Incidence of Cerebral Desaturation Events
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)

Detailed Description

Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
July 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Glenn Murphy

Director, Cardiac Anesthesia and Clinical Research

NorthShore University HealthSystem

Eligibility Criteria

Inclusion Criteria

  • Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.

Exclusion Criteria

  • Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age \< 18 years 3) American Society of Anesthesiologists Physical Status IV or V.

Outcomes

Primary Outcomes

Incidence of Cerebral Desaturation Events

Time Frame: Intraoperative-first 2 hours

Cerebral desaturation events were measured with near-infrared spectroscopy

Secondary Outcomes

  • Number of Patients Experiencing Nausea and Vomiting(Postanesthesia care unit-first 2 hours)
  • Postanesthesia Care Unit Length of Stay (Total Time)(Approximately 5 hours)

Study Sites (1)

Loading locations...

Similar Trials