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Hypercapnia During Shoulder Arthroscopy

Primary Purpose

Cerebral Ischemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hypercapnia
normocapnia
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Ischemia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    normocapnia

    hypercapnia

    Arm Description

    Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg

    Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg

    Outcomes

    Primary Outcome Measures

    Regional cerebral oxygen saturation

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2015
    Last Updated
    December 28, 2015
    Sponsor
    Gachon University Gil Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02643030
    Brief Title
    Hypercapnia During Shoulder Arthroscopy
    Official Title
    The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gachon University Gil Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Ischemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    normocapnia
    Arm Type
    Experimental
    Arm Description
    Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
    Arm Title
    hypercapnia
    Arm Type
    Active Comparator
    Arm Description
    Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
    Intervention Type
    Behavioral
    Intervention Name(s)
    hypercapnia
    Other Intervention Name(s)
    ETCO2-45
    Intervention Description
    Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
    Intervention Type
    Behavioral
    Intervention Name(s)
    normocapnia
    Other Intervention Name(s)
    ETCO2-35
    Intervention Description
    Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyung Cheon Lee, MD
    Organizational Affiliation
    Gachon University Gil Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16171668
    Citation
    Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.
    Results Reference
    result

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    Hypercapnia During Shoulder Arthroscopy

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