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Completed

NCT Number: NCT01535274

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspired oxygen fraction / end tidal carbon dioxide

Other

Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:

  • FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
  • FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
  • FIO2 100%, PETCO2 30mmHg - beach chair position.
  • FIO2 100%, PETCO2 45mmHg - beach chair position.
  • FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2012
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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