Comparison of iGel and THRIVE on Bronchoscopic Interventions

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Tracheal Diseases; Total Intravenous Anesthesia
• Intervention / Treatment: Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.; Procedure: postoperative recovery

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria:

• awake bronchoscopy pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difficulty of bronchoscopic approach	time from insertion to visualize vocal cord, records of manipulations if applied	from bronchoscopic insertion to visualize vocal cords
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Tracheal Diseases
• Other Study ID Numbers: 202011092RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: if there is similar investigation
• IPD Sharing Time Frame: 1 year after completion of investigation
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No