Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Inspired oxygen fraction / end tidal carbon dioxide

• Registration Number: NCT01535274
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2022-01-21
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Results First Posted: 2022-04-06
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane	Inspired oxygen fraction / end tidal carbon dioxide	Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.
Propofol	Inspired oxygen fraction / end tidal carbon dioxide	Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States