Comparison of iGel and THRIVE on Bronchoscopic Interventions

Overview

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.

Full Title of Study: “Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

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.

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
  • Procedure: postoperative recovery
    • anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • difficulty of bronchoscopic approach
    • Time Frame: from bronchoscopic insertion to visualize vocal cords
    • time from insertion to visualize vocal cord, records of manipulations if applied
  • response to spraying local anesthetics by bronchoscopy
    • Time Frame: 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 Measures

  • hemodynamic changes
    • Time Frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
    • changes on MAP (mmHg)
  • cough scale
    • Time Frame: from bronchoscopic insertion to the end of procedure
    • cough intensity X times
  • SPO2
    • Time Frame: every 5 minutes from bronchoscopic insertion to the end of procedure
    • pulse oximeter, hemoglobin saturation (%)
  • Transdermal CO2
    • Time Frame: every 5 minutes from bronchoscopic insertion to the end of procedure
    • data obyenied from transdermal CO2 (mmHg)
  • postanesthetic recovery
    • Time Frame: from admission to PACU to discharge from PACU
    • time stay in postoperative care unit (minutes)

Participating in This Clinical Trial

Inclusion Criteria

  • plan to receive bronchoscopic interventions with total intravenous anesthesia Exclusion Criteria:

  • awake bronchoscopy pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fu-Chang Tsai, Study Chair, National Taiwan University Hospital

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