Back to resultsComparison of iGel and THRIVE on Bronchoscopic Interventions
Primary Purpose
Lung Diseases, Total Intravenous Anesthesia, Tracheal Diseases
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.
postoperative recovery
Sponsored by
About this trial
This is an interventional prevention trial for Lung Diseases
Eligibility Criteria
Inclusion Criteria:
- plan to receive bronchoscopic interventions with total intravenous anesthesia
Exclusion Criteria:
- awake bronchoscopy pregnancy
Sites / Locations
- National Taiwan University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high-flow nasal oxygen
supraglottic devise
Arm Description
THRIVE( Transnasal humidified rapid-insufflation ventilatory exchange), a method of high-flow nasal oxygen (HFNO), is planned to applied for bronchoscopic interventions
iGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions
Outcomes
Primary Outcome Measures
difficulty of bronchoscopic approach
time from insertion to visualize vocal cord, records of manipulations if applied
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
Secondary Outcome Measures
hemodynamic changes
changes on MAP (mmHg)
cough scale
cough intensity X times
SPO2
pulse oximeter, hemoglobin saturation (%)
Transdermal CO2
data obyenied from transdermal CO2 (mmHg)
postanesthetic recovery
time stay in postoperative care unit (minutes)
Full Information
NCT ID
NCT05046223
First Posted
August 13, 2021
Last Updated
February 15, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05046223
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Total Intravenous Anesthesia, Tracheal Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high-flow nasal oxygen
Arm Type
Experimental
Arm Description
THRIVE( Transnasal humidified rapid-insufflation ventilatory exchange), a method of high-flow nasal oxygen (HFNO), is planned to applied for bronchoscopic interventions
Arm Title
supraglottic devise
Arm Type
Active Comparator
Arm Description
iGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions
Intervention Type
Procedure
Intervention Name(s)
The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.
Other Intervention Name(s)
hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions
Intervention Description
cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions
Intervention Type
Procedure
Intervention Name(s)
postoperative recovery
Intervention Description
anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1
Primary Outcome Measure Information:
Title
difficulty of bronchoscopic approach
Description
time from insertion to visualize vocal cord, records of manipulations if applied
Time Frame
from bronchoscopic insertion to visualize vocal cords
Title
response to spraying local anesthetics by bronchoscopy
Description
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
Time Frame
from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi
Secondary Outcome Measure Information:
Title
hemodynamic changes
Description
changes on MAP (mmHg)
Time Frame
from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Title
cough scale
Description
cough intensity X times
Time Frame
from bronchoscopic insertion to the end of procedure
Title
SPO2
Description
pulse oximeter, hemoglobin saturation (%)
Time Frame
every 5 minutes from bronchoscopic insertion to the end of procedure
Title
Transdermal CO2
Description
data obyenied from transdermal CO2 (mmHg)
Time Frame
every 5 minutes from bronchoscopic insertion to the end of procedure
Title
postanesthetic recovery
Description
time stay in postoperative care unit (minutes)
Time Frame
from admission to PACU to discharge from PACU
Other Pre-specified Outcome Measures:
Title
EAT-10 questionnaire (score):0-40
Description
EAT-10 for postbronchoscopic swallowing dysfunction, from 0 (normal swallowing) to 40 (extreme difficulty on swallowing)
Time Frame
preoperative and postoperative day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
plan to receive bronchoscopic interventions with total intravenous anesthesia
Exclusion Criteria:
awake bronchoscopy pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fu-Chang Tsai
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Cancer Center
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
if there is similar investigation
IPD Sharing Time Frame
1 year after completion of investigation
Learn more about this trial
Comparison of iGel and THRIVE on Bronchoscopic Interventions
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