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Transnasal Humidified Rapid Insufflation System for Intubation

Primary Purpose

Hypoxemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transnasal humidified rapid insufflation ventilator exchange
Conventional face mask
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who scheduled for elective lung surery with one lung ventilation

Exclusion Criteria:

  • suspicious difficult intubation (BMI >35kg/m2, mouth opening < 3 finger, Mallampati G >3), Room air SpO2 < 90%, active pulmonary infection, emergency operation, pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Control

    THRIVE

    Arm Description

    usual mask ventilation during anethesia induction

    Applying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction

    Outcomes

    Primary Outcome Measures

    Desaturation
    number of patients who experienced SpO2 under 93%

    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
    NCT04238351
    Brief Title
    Transnasal Humidified Rapid Insufflation System for Intubation
    Official Title
    Effect of Transnasal Humidified Rapid Insufflation Ventilator Exchange During Anesthesia Induction With Double Lumen Endotracheal Tube
    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
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction
    Detailed Description
    Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Applying Transnasal humidified rapid insufflation ventilator exchange
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Participants, care giver and outcome assessor can not know the group assingment.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Experimental
    Arm Description
    usual mask ventilation during anethesia induction
    Arm Title
    THRIVE
    Arm Type
    Active Comparator
    Arm Description
    Applying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction
    Intervention Type
    Device
    Intervention Name(s)
    Transnasal humidified rapid insufflation ventilator exchange
    Intervention Description
    applying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional face mask
    Intervention Description
    applying oxygen using usual face mask
    Primary Outcome Measure Information:
    Title
    Desaturation
    Description
    number of patients who experienced SpO2 under 93%
    Time Frame
    during the anesthesia induciton

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who scheduled for elective lung surery with one lung ventilation Exclusion Criteria: suspicious difficult intubation (BMI >35kg/m2, mouth opening < 3 finger, Mallampati G >3), Room air SpO2 < 90%, active pulmonary infection, emergency operation, pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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