NCT05046223

Brief Summary

THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. However, besides the risk of desaturation, the differences on difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are rarely investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

August 13, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

August 13, 2021

Last Update Submit

February 15, 2023

Conditions

Lung DiseasesTotal Intravenous AnesthesiaTracheal Diseases

Outcome Measures

Primary Outcomes (2)

  • difficulty of bronchoscopic approach

    time from insertion to visualize vocal cord, records of manipulations if applied

    from bronchoscopic insertion to visualize vocal cords

  • response to spraying local anesthetics by bronchoscopy

    the status of vocal cords visualized (relaxed, closed, relaxed but close with spray of local anesthetics); cough scale during bronchoscopic insertion and spray of local anesthetics

    from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi

Secondary Outcomes (5)

  • hemodynamic changes

    from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

  • cough scale

    from bronchoscopic insertion to the end of procedure

  • SPO2

    every 5 minutes from bronchoscopic insertion to the end of procedure

  • Transdermal CO2

    every 5 minutes from bronchoscopic insertion to the end of procedure

  • postanesthetic recovery

    from admission to PACU to discharge from PACU

Other Outcomes (1)

  • EAT-10 questionnaire (score):0-40

    preoperative and postoperative day 1

Study Arms (2)

high-flow nasal oxygen

EXPERIMENTAL

THRIVE( Transnasal humidified rapid-insufflation ventilatory exchange), a method of high-flow nasal oxygen (HFNO), is planned to applied for bronchoscopic interventions

Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.Procedure: postoperative recovery

supraglottic devise

ACTIVE COMPARATOR

iGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions

Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.Procedure: postoperative recovery

Interventions

The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.PROCEDURE

cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions

Also known as: hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions
high-flow nasal oxygensupraglottic devise
postoperative recoveryPROCEDURE

anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1

high-flow nasal oxygensupraglottic devise

Eligibility Criteria

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

You may qualify if:

  • plan to receive bronchoscopic interventions with total intravenous anesthesia

You may not qualify if:

  • awake bronchoscopy pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Cancer Center

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lung DiseasesTracheal Diseases

Interventions

CryotherapyHemodynamics

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Fu-Chang Tsai

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

September 16, 2021

Study Start

August 20, 2021

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

if there is similar investigation

Shared Documents
CSR
Time Frame
1 year after completion of investigation

Locations

TW(1)