The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

NCT ID: NCT01546636

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-07-31

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.

Conditions

Cerebral Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hypocapnic group

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

Group Type: PLACEBO_COMPARATOR

Hypocapnic group

Intervention Type: OTHER

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

Normocapnic group

Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Group Type: ACTIVE_COMPARATOR

Normocapnic group

Intervention Type: OTHER

Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Interventions

Hypocapnic group

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

Intervention Type: OTHER

Normocapnic group

Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Glenn Murphy

Director, Cardiac Anesthesia and Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glenn S. Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem

Evanston, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24860157 (View on PubMed)

Other Identifiers

EH10-184

Identifier Type: -

Identifier Source: org_study_id