Comparison of iGel and THRIVE on Bronchoscopic Interventions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Diseases, Total Intravenous Anesthesia, Tracheal Diseases

Intervention / Treatment
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* Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.
* Procedure: postoperative recovery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: plan to receive bronchoscopic interventions with total intravenous anesthesia Exclusion Criteria: awake bronchoscopy pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-flow nasal oxygen<br>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.<br>* cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions<br>* Other names: hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions;Procedure: postoperative recovery<br>* anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1<br>|
| Active Comparator: supraglottic devise<br>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.<br>* cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions<br>* Other names: hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions;Procedure: postoperative recovery<br>* anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1<br>|

What is the study measuring?
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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 |