NCT04238351

Brief Summary

Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

January 20, 2020

Last Update Submit

February 16, 2020

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

  • Desaturation

    number of patients who experienced SpO2 under 93%

    during the anesthesia induciton

Study Arms (2)

Control

EXPERIMENTAL

usual mask ventilation during anethesia induction

Device: Conventional face mask

THRIVE

ACTIVE COMPARATOR

Applying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction

Device: Transnasal humidified rapid insufflation ventilator exchange

Interventions

Transnasal humidified rapid insufflation ventilator exchangeDEVICE

applying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min.

THRIVE
Conventional face maskDEVICE

applying oxygen using usual face mask

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, care giver and outcome assessor can not know the group assingment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Applying Transnasal humidified rapid insufflation ventilator exchange
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 23, 2020

Study Start

February 25, 2020

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share