Comparison of iGel and THRIVE on Bronchoscopic Interventions
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
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 Design
Arms and Interventions
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:
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:
Procedure: postoperative recovery
anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1
|
Outcome Measures
Primary Outcome Measures
- difficulty of bronchoscopic approach [from bronchoscopic insertion to visualize vocal cords]
time from insertion to visualize vocal cord, records of manipulations if applied
- 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
Secondary Outcome Measures
- 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
- 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)
- postanesthetic recovery [from admission to PACU to discharge from PACU]
time stay in postoperative care unit (minutes)
Other Outcome Measures
- EAT-10 questionnaire (score):0-40 [preoperative and postoperative day 1]
EAT-10 for postbronchoscopic swallowing dysfunction, from 0 (normal swallowing) to 40 (extreme difficulty on swallowing)
Eligibility Criteria
Criteria
Inclusion Criteria:
- plan to receive bronchoscopic interventions with total intravenous anesthesia
Exclusion Criteria:
- awake bronchoscopy pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Taiwan University Cancer Center | Taipei | Taiwan |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Study Chair: Fu-Chang Tsai, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202011092RINA