Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter

NCT ID: NCT03846713

Last Updated: 2025-06-25

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-27

Study Completion Date

2019-05-31

Brief Summary

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The purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.

Detailed Description

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Conditions

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Intubation Complication Hoarseness Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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non-thermosoftening

Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.

Group Type ACTIVE_COMPARATOR

non-thermosoftening

Intervention Type PROCEDURE

By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.

thermosoftening

Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.

Group Type EXPERIMENTAL

thermosoftening

Intervention Type PROCEDURE

By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).

Interventions

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non-thermosoftening

By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.

Intervention Type PROCEDURE

thermosoftening

By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes

Exclusion Criteria

* Preoperative hoarseness or a sore throat
* History of upper airway diseases
* Anticipated difficult airway
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Hyon Bahk, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Hyon Bahk, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JHBahk_DLT_AEC

Identifier Type: -

Identifier Source: org_study_id

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