The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

September 12, 2019 updated by: Glenn Murphy, NorthShore University HealthSystem
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Other: Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Active Comparator: Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Other: Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Cerebral Desaturation Events
Time Frame: Intraoperative-first 2 hours
Cerebral desaturation events were measured with near-infrared spectroscopy
Intraoperative-first 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH10-184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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