Adequate Additional Bronchial Cuff Volume to Achieve Blood-tight Seal After Air-tight Seal in Double Lumen Tube

NCT ID: NCT01979640

Last Updated: 2016-04-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube

Detailed Description

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Conditions

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Preventing Blood Leakage of Bronchial Cuff

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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39 Fr double lumen group

patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube

Group Type EXPERIMENTAL

39 Fr double lumen tube group

Intervention Type PROCEDURE

additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml

37 Fr double lumen group

patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube

Group Type EXPERIMENTAL

37 Fr double lumen tube group

Intervention Type PROCEDURE

additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml

35 Fr double lumen tube group

patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube

Group Type EXPERIMENTAL

35 Fr double lumen tube group

Intervention Type PROCEDURE

additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml

Interventions

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39 Fr double lumen tube group

additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml

Intervention Type PROCEDURE

37 Fr double lumen tube group

additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml

Intervention Type PROCEDURE

35 Fr double lumen tube group

additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing thoracic surgery under left lower decubitus position, using left sided double lumen tube
* patient's left main bronchus size adequate for 35Fr, 37 Fr, 39 Fr double lumen tube

Exclusion Criteria

* dislocation or great movement of double lumen tube depth
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 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

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae-Hyon Bahk, MD, PhD

Role: CONTACT

82-2-2072-2818

Facility Contacts

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Jae-Hyon Bahk, MD, PhD

Role: primary

82-2-2072-2818

Other Identifiers

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JHBahk_DLT_bloodtightseal

Identifier Type: -

Identifier Source: org_study_id

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