Comparison of iGel and THRIVE on Bronchoscopic Interventions

Not Applicable

Completed

• Conditions: Lung Diseases; Total Intravenous Anesthesia; Tracheal Diseases

• Registration Number: NCT05046223
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-13
• Study Start: 2021-08-20
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria

• awake bronchoscopy pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
difficulty of bronchoscopic approach	from bronchoscopic insertion to visualize vocal cords	time from insertion to visualize vocal cord, records of manipulations if applied

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan