The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
1 other identifier
interventional
70
1 country
1
Brief Summary
The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 2, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
December 17, 2013
CompletedSeptember 30, 2019
September 1, 2019
2.7 years
March 2, 2012
July 16, 2013
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Cerebral Desaturation Events
Cerebral desaturation events were measured with near-infrared spectroscopy
Intraoperative-first 2 hours
Secondary Outcomes (2)
Number of Patients Experiencing Nausea and Vomiting
Postanesthesia care unit-first 2 hours
Postanesthesia Care Unit Length of Stay (Total Time)
Approximately 5 hours
Study Arms (2)
Hypocapnic group
PLACEBO COMPARATORPatients will be ventilated to an ETCO2 of 30-32 mm Hg.
Normocapnic group
ACTIVE COMPARATORPatients will be ventilated to an ETCO2 of 40-42 mm Hg
Interventions
Eligibility Criteria
You may qualify if:
- Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
Study Sites (1)
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Related Publications (1)
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Levin SD, Koh JL, Parikh KN, Patel SS. Effect of ventilation on cerebral oxygenation in patients undergoing surgery in the beach chair position: a randomized controlled trial. Br J Anaesth. 2014 Oct;113(4):618-27. doi: 10.1093/bja/aeu109. Epub 2014 May 23.
PMID: 24860157DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
There were no technical limitations to the trial
Results Point of Contact
- Title
- Glenn Murphy, MD, Director of Clinical Research
- Organization
- NorthShore University HealthSystem
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn S. Murphy, MD
Endeavor Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Cardiac Anesthesia and Clinical Research
Study Record Dates
First Submitted
March 2, 2012
First Posted
March 7, 2012
Study Start
November 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
September 30, 2019
Results First Posted
December 17, 2013
Record last verified: 2019-09