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

NCT01535274 | Completed Results DMC

• 1 other identifier: HUM00049747
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Cerebral oxygenation; Beach chair position; General anesthetic technique; Inspired oxygen fraction; End tidal carbon dioxide

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Desflurane

EXPERIMENTAL

Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.

Other: Inspired oxygen fraction / end tidal carbon dioxide

Propofol

EXPERIMENTAL

Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.

Other: Inspired oxygen fraction / end tidal carbon dioxide

Interventions

Inspired oxygen fraction / end tidal carbon dioxide OTHER

Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve: 1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. 2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. 3. FIO2 100%, PETCO2 30mmHg - beach chair position. 4. FIO2 100%, PETCO2 45mmHg - beach chair position. 5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.

Desflurane; Propofol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Picton P, Dering A, Miller B, Shanks A, Mashour GA. The influence of basic ventilation strategies and anesthetic techniques on cerebral oxygenation in the beach chair position: study protocol. BMC Anesthesiol. 2012 Sep 20;12:23. doi: 10.1186/1471-2253-12-23.

  PMID: 22994896 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Paul Picton
• Organization: University of Michigan

ppicton@umich.edu

734-936-4280

Study Officials

• Paul Picton, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 17, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 6, 2022
• Results First Posted: April 6, 2022

Record last verified: 2022-04

Locations

US (1)