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

April 19, 2016 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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
Experimental: 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
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
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
leakage of autologus blood through bronchial cuff
Time Frame: 10, 20, 30 minutes after dripping of blood around bronchial cuff
10, 20, 30 minutes after dripping of blood around bronchial cuff

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 3, 2013

First Submitted That Met QC Criteria

November 3, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JHBahk_DLT_bloodtightseal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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