Clinical trial NCT05046223: Comparison of iGel and THRIVE on Bronchoscopic Interventions
Official title: Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Total Intravenous Anesthesia
Tracheal Diseases
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria:

* awake bronchoscopy pregnancy

Primary outcomes:
measure: difficulty of bronchoscopic approach
timeFrame: from bronchoscopic insertion to visualize vocal cords
measure: response to spraying local anesthetics by bronchoscopy
timeFrame: from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi
Secondary outcomes:
measure: hemodynamic changes
timeFrame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
measure: cough scale
timeFrame: from bronchoscopic insertion to the end of procedure
measure: SPO2
timeFrame: every 5 minutes from bronchoscopic insertion to the end of procedure
measure: Transdermal CO2
timeFrame: every 5 minutes from bronchoscopic insertion to the end of procedure
measure: postanesthetic recovery
timeFrame: from admission to PACU to discharge from PACU
Other outcomes:
measure: EAT-10 questionnaire (score):0-40
timeFrame: preoperative and postoperative day 1
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
Study officials:
affiliation: National Taiwan University Hospital
name: Fu-Chang Tsai
role: STUDY_CHAIR
References: