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Effect of Alveolar Recruitment Maneuver on Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alveolar recruitment maneuver
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who scheduled for elective bariatric surgery

Exclusion Criteria:

  • uncontrolled cardio-vascular disease, active pulmonary disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Control

    Low ARM

    High ARM

    Arm Description

    no applying alveolar recuritment maneuver

    Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec

    Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec

    Outcomes

    Primary Outcome Measures

    numeric rating scale for postoperative pain
    score (0 no pain-10 severe pain)
    Quality of recovery (QoR40) for Postoperative comfort
    score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2020
    Last Updated
    February 16, 2020
    Sponsor
    Gachon University Gil Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04259918
    Brief Title
    Effect of Alveolar Recruitment Maneuver on Postoperative Pain
    Official Title
    Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 25, 2020 (Anticipated)
    Primary Completion Date
    November 30, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O
    Detailed Description
    After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    enrolled groups ares only selected and applied in the operating room and participants, care giver and outcomes accessor could not know the group assignment
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Experimental
    Arm Description
    no applying alveolar recuritment maneuver
    Arm Title
    Low ARM
    Arm Type
    Active Comparator
    Arm Description
    Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec
    Arm Title
    High ARM
    Arm Type
    Active Comparator
    Arm Description
    Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec
    Intervention Type
    Procedure
    Intervention Name(s)
    Alveolar recruitment maneuver
    Other Intervention Name(s)
    Low pressure alveolar recruitment maneuver, High pressure alveolar recruitment maneuver
    Intervention Description
    Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery
    Primary Outcome Measure Information:
    Title
    numeric rating scale for postoperative pain
    Description
    score (0 no pain-10 severe pain)
    Time Frame
    up to postoperative 24 hour
    Title
    Quality of recovery (QoR40) for Postoperative comfort
    Description
    score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
    Time Frame
    up to postoperative 24 hour

    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 who scheduled for elective bariatric surgery Exclusion Criteria: uncontrolled cardio-vascular disease, active pulmonary disorder

    12. IPD Sharing Statement

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