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CompletedNCT00969683Updated Sep 23, 2016

Double-Lumen Tube With or Without a Carinal Hook

An interventional study of Tracheal intubation and Tracheal intubation in Anesthesia, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Hopital Foch · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients scheduled for lung surgery requiring one-lung ventilation

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • ASA class 4
  • prevision of difficult intubation or of pulmonary aspiration
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
184 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceTracheal intubation

    Tracheal intubation using a Double lumen tube without a hook

  • DeviceTracheal intubation

    Tracheal intubation with a Double lumen tube with a hook

06

What researchers measure

Primary outcomes

  1. time required to initially position the assigned tube

    Time frame: end of anesthesia

Secondary outcomes

  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

07

Study locations

1 site
  • Service d'Anesthésie, Hôpital Foch
    Suresnes, 92150, France
08

References and documents

Publications

  • 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. PubMed 25489763 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00969683
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Sep 1, 2009
Start date
Aug 2009
Primary completion
Dec 2012
Completion
May 2013
Last update
Sep 23, 2016

Study contacts

Marc Fischler, MD
study chair · Hôpital Foch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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