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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535274
• Other study ID #: HUM00049747
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Inspired oxygen fraction / end tidal carbon dioxide
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy	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.	duration of surgery, generally no more than 90 minutes total
Primary	Regional Cerebral Oxygenation (rSO2) Values	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.	duration of surgery, generally no more than 90 minutes total