Skip to main content
Clinical Trials/NCT01535274
NCT01535274
Completed
Not Applicable

The Influence of Basic Ventilation Strategies and Anesthetic Techniques on Cerebral Oxygenation in the Beach Chair Position

University of Michigan1 site in 1 country67 target enrollmentSeptember 2012
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Michigan
Enrollment
67
Locations
1
Primary Endpoint
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. As such, poor neurological outcome following beach chair positioning is a growing concern. In the proposed study the investigators test the hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral oxygenation in anesthetized patients in the beach chair position.

Detailed Description

This is a prospective cohort study with randomized nested design. Patients presenting for shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia with propofol. Regional cerebral oxygenation will be measured using the INVOS 5100C monitor (Covidien, Boulder, CO). Depth of anesthesia will be maintained within a Bispectral Index range of 40-60. Following positioning, inspired oxygen fraction and minute ventilation will be sequentially adjusted. At each set point, regional cerebral oxygenation will be recorded and venous blood gas analysis performed. Statistical analysis will be repeated measures analysis of variance in which ventilation strategy is the within-subjects factor and anesthetic technique is the between-subjects factor; post hoc Tukey's correction will be used for multiple comparisons. If simple maneuvers of ventilation and anesthetic technique can prevent low brain oxygen levels, patient outcome may be improved.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Picton

Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • scheduled for elective arthroscopic shoulder surgery in the beach chair position under general anesthesia with supplemental interscalene block

Exclusion Criteria

  • refusal to give consent
  • ineligible for interscalene block
  • history of cardiovascular disease
  • history of cerebrovascular disease
  • hypertension
  • respiratory failure
  • non-English speaker

Outcomes

Primary Outcomes

Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy

Time Frame: duration of surgery, generally no more than 90 minutes total

rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. With each set point, the value shown is the absolute change from baseline.

Regional Cerebral Oxygenation (rSO2) Values

Time Frame: duration of surgery, generally no more than 90 minutes total

Regional cerebral oxygenation (rSO2) values at the set ventilatory points of the study for each anesthetic choice. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.

Study Sites (1)

Loading locations...

Similar Trials