Double-Lumen Tube With or Without a Carinal Hook

Sponsor

Hopital Foch (Other)

Overall Status

Completed

CT.gov ID

NCT00969683

Collaborator

(none)

184

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: Tracheal intubation Device: Tracheal intubation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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
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 with a Double lumen tube with a hook

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

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 with a Double lumen tube with a hook

Outcome Measures

Primary Outcome Measures

time required to initially position the assigned tube [end of anesthesia]

Secondary Outcome Measures

degree of lung collapse [end of anesthesia]
number of intraoperatively FOB examinations [end of anesthesia]
Glottic or tracheo-bronchial lesion [end of hospitalisation]
Sore throat or hoarse voice [end of hospitalisation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'Anesthésie, Hôpital Foch	Suresnes		France	92150

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair: Marc Fischler, MD, Hôpital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Foch

ClinicalTrials.gov Identifier:

NCT00969683

Other Study ID Numbers:

2009/21

First Posted:

Sep 1, 2009

Last Update Posted:

Sep 23, 2016

Last Verified:

Sep 1, 2016

Study Results

No Results Posted as of Sep 23, 2016