Comparison of iGel and THRIVE on Bronchoscopic Interventions

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05046223
Collaborator
(none)
120
1
2
16.4
7.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.
  • Procedure: postoperative recovery
N/A

Detailed Description

THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. Unlike the nasal cannula with THRIVE, the tips of iGel are located in upper esophagi, it may affect the postoperative swallowing, especially for the aged group. However, the bronchoscopic approach may be easier for an established route to vocal cords. With shared airway for ventilation and interventions, CO2 elimination is hardly monitored besides the risk of desaturation.

In this study, THRIVE or iGel was planned to be randomized used for bronchoscopic interventions in an adult group (age 20-65) and an aged group (age over 65). The 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 compared between THRIVE and iGel groups.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management
Actual Study Start Date :
Aug 20, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: high-flow nasal oxygen

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.
cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions
Other Names:
  • hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions
  • Procedure: postoperative recovery
    anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1

    Active Comparator: supraglottic devise

    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.
    cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions
    Other Names:
  • hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions
  • Procedure: postoperative recovery
    anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1

    Outcome Measures

    Primary Outcome Measures

    1. difficulty of bronchoscopic approach [from bronchoscopic insertion to visualize vocal cords]

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

    2. response to spraying local anesthetics by bronchoscopy [from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi]

      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

    Secondary Outcome Measures

    1. hemodynamic changes [from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying]

      changes on MAP (mmHg)

    2. cough scale [from bronchoscopic insertion to the end of procedure]

      cough intensity X times

    3. SPO2 [every 5 minutes from bronchoscopic insertion to the end of procedure]

      pulse oximeter, hemoglobin saturation (%)

    4. Transdermal CO2 [every 5 minutes from bronchoscopic insertion to the end of procedure]

      data obyenied from transdermal CO2 (mmHg)

    5. postanesthetic recovery [from admission to PACU to discharge from PACU]

      time stay in postoperative care unit (minutes)

    Other Outcome Measures

    1. EAT-10 questionnaire (score):0-40 [preoperative and postoperative day 1]

      EAT-10 for postbronchoscopic swallowing dysfunction, from 0 (normal swallowing) to 40 (extreme difficulty on swallowing)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • plan to receive bronchoscopic interventions with total intravenous anesthesia
    Exclusion Criteria:
    • awake bronchoscopy pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Cancer Center Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Chair: Fu-Chang Tsai, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05046223
    Other Study ID Numbers:
    • 202011092RINA
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 5, 2022