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Clinical Trials/NCT05046223
NCT05046223
Completed
Not Applicable

Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management

National Taiwan University Hospital1 site in 1 country160 target enrollmentAugust 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Diseases
Sponsor
National Taiwan University Hospital
Enrollment
160
Locations
1
Primary Endpoint
response to spraying local anesthetics by bronchoscopy
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2021
End Date
January 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria

  • awake bronchoscopy pregnancy

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • hemodynamic changes(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)
  • cough scale(from bronchoscopic insertion to the end of procedure)
  • postanesthetic recovery(from admission to PACU to discharge from PACU)
  • 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)

Study Sites (1)

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