Double-Lumen Tube With or Without a Carinal Hook

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Tracheal intubation

• Registration Number: NCT00969683
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• patients scheduled for lung surgery requiring one-lung ventilation

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double lumen tube without a hook	Tracheal intubation	Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
Double lumen tube with a hook	Tracheal intubation	Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex

Primary Outcome Measures

Name	Time	Method
time required to initially position the assigned tube	end of anesthesia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service d'Anesthésie, Hôpital Foch; 🇫🇷 Suresnes, France