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
About this trial
This is an interventional prevention trial for Hypoxemia
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
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
NCT ID
NCT04238351
First Posted
January 20, 2020
Last Updated
February 16, 2020
Sponsor
Gachon University Gil Medical Center
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
Learn more about this trial
Transnasal Humidified Rapid Insufflation System for Intubation
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