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Double-Lumen Tube With or Without a Carinal Hook

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00969683
First received: August 28, 2009
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Anesthesia
 Device: Tracheal intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • time required to initially position the assigned tube [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • degree of lung collapse [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • number of intraoperatively FOB examinations [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • Glottic or tracheo-bronchial lesion [ Time Frame: end of hospitalisation ] [ Designated as safety issue: No ]
  • Sore throat or hoarse voice [ Time Frame: end of hospitalisation ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: August 2009
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969683

Locations
France
Service d'Anesthésie, Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00969683     History of Changes
Other Study ID Numbers: 2009/21
Study First Received: August 28, 2009
Last Updated: May 9, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 16, 2013