Comparison of iGel and THRIVE on Bronchoscopic Interventions

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046223
• Other study ID #: 202011092RINA
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria:

• awake bronchoscopy pregnancy

Related Conditions & MeSH terms

• Lung Diseases
• Total Intravenous Anesthesia
• Tracheal Diseases

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Cancer Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EAT-10 questionnaire (score):0-40	EAT-10 for postbronchoscopic swallowing dysfunction, from 0 (normal swallowing) to 40 (extreme difficulty on swallowing)	preoperative and postoperative day 1
Primary	difficulty of bronchoscopic approach	time from insertion to visualize vocal cord, records of manipulations if applied	from bronchoscopic insertion to visualize vocal cords
Primary	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	hemodynamic changes	changes on MAP (mmHg)	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Secondary	cough scale	cough intensity X times	from bronchoscopic insertion to the end of procedure
Secondary	SPO2	pulse oximeter, hemoglobin saturation (%)	every 5 minutes from bronchoscopic insertion to the end of procedure
Secondary	Transdermal CO2	data obyenied from transdermal CO2 (mmHg)	every 5 minutes from bronchoscopic insertion to the end of procedure
Secondary	postanesthetic recovery	time stay in postoperative care unit (minutes)	from admission to PACU to discharge from PACU