Comparison of iGel and THRIVE on Bronchoscopic Interventions

NCT05046223 — Not applicable, Completed, 160 participants, National Taiwan University Hospital

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

RegistryNCT05046223
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, prevention
Enrollment160 (Actual)
SponsorNational Taiwan University Hospital (Other)
ConditionsLung Diseases, Total Intravenous Anesthesia, Tracheal Diseases
InterventionsThe responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc., postoperative recovery (Procedure)
Datesstart 2021-08-20, primary completion 2022-12-31, completion 2023-01-31, first posted 2021-09-16, last updated 2023-02-16
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Lung Diseases All trials for Total Intravenous Anesthesia All trials of The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc. All trials of postoperative recovery

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
high-flow nasal oxygenExperimentalProcedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.; Procedure: postoperative recoveryTHRIVE( Transnasal humidified rapid-insufflation ventilatory exchange), a method of high-flow nasal oxygen (HFNO), is planned to applied for bronchoscopic interventions
supraglottic deviseActive comparatorProcedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.; Procedure: postoperative recoveryiGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions
  • The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc. (Procedure), also known as hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions: cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions
  • postoperative recovery (Procedure): anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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 outcomes

  • 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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria:

* awake bronchoscopy pregnancy

+Locations (1)

FacilityCityCountryStatus
National Taiwan University Cancer CenterTaipeiTaiwan

+Investigators