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Comparison of iGel and THRIVE on Bronchoscopic Interventions

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05046223
Enrollment
160
Registered
2021-09-16
Start date
2021-08-20
Completion date
2023-01-31
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Total Intravenous Anesthesia, Tracheal Diseases

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.

Interventions

PROCEDUREThe 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

PROCEDUREpostoperative recovery

anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion criteria

* awake bronchoscopy pregnancy

Design outcomes

Primary

MeasureTime frameDescription
response to spraying local anesthetics by bronchoscopyfrom visualizng vocal cords to complete local anesthetic spray in trachea and main bronchithe 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
difficulty of bronchoscopic approachfrom bronchoscopic insertion to visualize vocal cordstime from insertion to visualize vocal cord, records of manipulations if applied

Secondary

MeasureTime frameDescription
cough scalefrom bronchoscopic insertion to the end of procedurecough intensity X times
SPO2every 5 minutes from bronchoscopic insertion to the end of procedurepulse oximeter, hemoglobin saturation (%)
postanesthetic recoveryfrom admission to PACU to discharge from PACUtime stay in postoperative care unit (minutes)
Transdermal CO2every 5 minutes from bronchoscopic insertion to the end of proceduredata obyenied from transdermal CO2 (mmHg)
hemodynamic changesfrom bronchoscopic insertion to 20 minutes after completion of local anesthetic sprayingchanges on MAP (mmHg)

Other

MeasureTime frameDescription
EAT-10 questionnaire (score):0-40preoperative and postoperative day 1EAT-10 for postbronchoscopic swallowing dysfunction, from 0 (normal swallowing) to 40 (extreme difficulty on swallowing)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026