Comparison of iGel and THRIVE on Bronchoscopic Interventions

NCT ID: NCT05046223

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Diseases Total Intravenous Anesthesia Tracheal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

postoperative recovery

Intervention Type PROCEDURE

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

supraglottic devise

iGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

postoperative recovery

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

postoperative recovery

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria

* awake bronchoscopy pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fu-Chang Tsai

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Cancer Center

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202011092RINA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.