Hypercapnia During Shoulder Arthroscopy

December 28, 2015 updated by: Youn Yi Jo, Gachon University Gil Medical Center

The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position

The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective shoulder arthroscopic surgery

Exclusion Criteria:

  • a history of age > 65 years, morbidly obesity (BMI > 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.

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
Experimental: normocapnia
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Behavioral: normocapnia
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Other Names:
  • ETCO2-35
Active Comparator: hypercapnia
Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Behavioral: hypercapnia
Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Other Names:
  • ETCO2-45

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Regional cerebral oxygen saturation
Time Frame: Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position
Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position

Collaborators and Investigators

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

Sponsor

Gachon University Gil Medical Center

Investigators

  • Study Chair: Kyung Cheon Lee, MD, Gachon University Gil Medical Center

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

March 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 28, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRBA2674-2012

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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