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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):

August 28, 2009
September 1, 2009
September 23, 2016
August 2009
December 2012   (Final data collection date for primary outcome measure)
time required to initially position the assigned tube [ Time Frame: end of anesthesia ]
Same as current
Complete list of historical versions of study NCT00969683 on ClinicalTrials.gov Archive Site
  • degree of lung collapse [ Time Frame: end of anesthesia ]
  • number of intraoperatively FOB examinations [ Time Frame: end of anesthesia ]
  • Glottic or tracheo-bronchial lesion [ Time Frame: end of hospitalisation ]
  • Sore throat or hoarse voice [ Time Frame: end of hospitalisation ]
Same as current
Not Provided
Not Provided
 
Double-Lumen Tube With or Without a Carinal Hook
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Anesthesia
  • 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
  • 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
    Intervention: Device: Tracheal intubation
  • 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
    Intervention: Device: Tracheal intubation
Dumans-Nizard V, Parquin JF, Moyer JD, Dreyfus JF, Fischler M, Le Guen M. Left double-lumen tube with or without a carinal hook: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jun;32(6):418-24. doi: 10.1097/EJA.0000000000000201.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
May 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00969683
2009/21
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP