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Completed

NCT Number: NCT05046223

Comparison of iGel and THRIVE on Bronchoscopic Interventions

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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases Total Intravenous Anesthesia Tracheal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion criteria

  • awake bronchoscopy pregnancy

Treatment and study plan

The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.

Procedure

cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions

Other names: hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions

postoperative recovery

Procedure

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

Primary outcomes

  1. difficulty of bronchoscopic approach

    Time frame: from bronchoscopic insertion to visualize vocal cords

    time from insertion to visualize vocal cord, records of manipulations if applied

  2. response to spraying local anesthetics by bronchoscopy

    Time frame: 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 outcomes

  1. hemodynamic changes

    Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

    changes on MAP (mmHg)

  2. cough scale

    Time frame: from bronchoscopic insertion to the end of procedure

    cough intensity X times

  3. SPO2

    Time frame: every 5 minutes from bronchoscopic insertion to the end of procedure

    pulse oximeter, hemoglobin saturation (%)

  4. Transdermal CO2

    Time frame: every 5 minutes from bronchoscopic insertion to the end of procedure

    data obyenied from transdermal CO2 (mmHg)

  5. postanesthetic recovery

    Time frame: from admission to PACU to discharge from PACU

    time stay in postoperative care unit (minutes)

Other outcomes

  1. EAT-10 questionnaire (score):0-40

    Time frame: preoperative and postoperative day 1

    EAT-10 for postbronchoscopic swallowing dysfunction, from 0 (normal swallowing) to 40 (extreme difficulty on swallowing)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 16, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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