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Double-Lumen Tube With or Without a Carinal Hook

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ClinicalTrials.gov Identifier: NCT00969683
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Anesthesia Device: Tracheal intubation Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2013

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




Primary Outcome Measures :
  1. time required to initially position the assigned tube [ Time Frame: end of anesthesia ]

Secondary Outcome Measures :
  1. degree of lung collapse [ Time Frame: end of anesthesia ]
  2. number of intraoperatively FOB examinations [ Time Frame: end of anesthesia ]
  3. Glottic or tracheo-bronchial lesion [ Time Frame: end of hospitalisation ]
  4. Sore throat or hoarse voice [ Time Frame: end of hospitalisation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969683


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00969683     History of Changes
Other Study ID Numbers: 2009/21
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016