The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

Not Applicable

Completed

• Conditions: Cerebral Ischemia
• Interventions: Other: Hypocapnic group; Other: Normocapnic group

• Registration Number: NCT01546636
• Lead Sponsor: NorthShore University HealthSystem

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2013-07-16
• Results First Submitted QC: 2013-11-22
• Results First Posted: 2013-12-17
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypocapnic group	Hypocapnic group	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Normocapnic group	Normocapnic group	Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Primary Outcome Measures

Name	Time	Method
Incidence of Cerebral Desaturation Events	Intraoperative-first 2 hours	Cerebral desaturation events were measured with near-infrared spectroscopy

Secondary Outcome Measures

Name	Time	Method
Number of Patients Experiencing Nausea and Vomiting	Postanesthesia care unit-first 2 hours	Assessed by recovery nurses
Postanesthesia Care Unit Length of Stay (Total Time)	Approximately 5 hours

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States