Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Other: Inspired oxygen fraction / end tidal carbon dioxide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Influence of Basic Ventilation Strategies and Anesthetic Techniques on Cerebral Oxygenation in the Beach Chair Position |
- Change in regional cerebral oxygenation (rSO2) before and 5 minutes after each change in ventilation strategy [ Time Frame: 2 years. ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 54 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Desflurane
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
Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
|
|
Experimental: Propofol
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
Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Amy Shanks, MS | 734-936-0063 | amysha@med.umich.edu |
| United States, Michigan | |
| University of Michigan | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Paul Picton, MB ChB | |
| Sub-Investigator: George A Mashour, MD PhD | |
| Sub-Investigator: Andrew Dering, MB BS | |
| Sub-Investigator: Bruce Miller, MD | |
| Sub-Investigator: Amy Shanks, MS | |
More Information
No publications provided
| Responsible Party: | Paul Picton, Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01535274 History of Changes |
| Other Study ID Numbers: | HUM00049747 |
| Study First Received: | February 9, 2012 |
| Last Updated: | August 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Cerebral oxygenation Beach chair position General anesthetic technique Inspired oxygen fraction End tidal carbon dioxide |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013