Double-Lumen Tube With or Without a Carinal Hook

September 22, 2016 updated by: Hopital Foch

Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery

Most teams use a left double-lumen tube. The double-lumen tube is available with or without a carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large in Europe and quite unknown in US. The literature is poor, containing only few case reports.

The purpose of this research is to compare the two types of left double-lumen tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

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

  • France
      • Suresnes, France, 92150
        • Service d'Anesthésie, Hôpital Foch

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for lung surgery requiring one-lung ventilation

Exclusion Criteria:

  • pregnancy
  • ASA class 4
  • prevision of difficult intubation or of pulmonary aspiration

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double lumen tube without a hook
Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
Device: Tracheal intubation
Tracheal intubation using a Double lumen tube without a hook
Device: Tracheal intubation
Tracheal intubation with a Double lumen tube with a hook
Experimental: Double lumen tube with a hook
Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
Device: Tracheal intubation
Tracheal intubation using a Double lumen tube without a hook
Device: Tracheal intubation
Tracheal intubation with a Double lumen tube with a hook

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time required to initially position the assigned tube
Time Frame: end of anesthesia
end of anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
degree of lung collapse
Time Frame: end of anesthesia
end of anesthesia
number of intraoperatively FOB examinations
Time Frame: end of anesthesia
end of anesthesia
Glottic or tracheo-bronchial lesion
Time Frame: end of hospitalisation
end of hospitalisation
Sore throat or hoarse voice
Time Frame: end of hospitalisation
end of hospitalisation

Collaborators and Investigators

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

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2009/21

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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