Clinical trial NCT01546636: The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
Official title: The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Ischemia
Keywords: Cerebral desaturation events
Cerebral oximetry
Beach chair position
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Detailed description: Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.

Eligibility criteria: Inclusion Criteria:

* Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.

Exclusion Criteria:

* Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age \< 18 years 3) American Society of Anesthesiologists Physical Status IV or V.

Primary outcomes:
measure: Incidence of Cerebral Desaturation Events
timeFrame: Intraoperative-first 2 hours
Secondary outcomes:
measure: Number of Patients Experiencing Nausea and Vomiting
timeFrame: Postanesthesia care unit-first 2 hours
measure: Postanesthesia Care Unit Length of Stay (Total Time)
timeFrame: Approximately 5 hours
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Glenn S. Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.