Double-Lumen Tube With or Without a Carinal Hook
Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery
1 other identifier
interventional
184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 28, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedSeptember 23, 2016
September 1, 2016
3.3 years
August 28, 2009
September 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
time required to initially position the assigned tube
end of anesthesia
Secondary Outcomes (4)
degree of lung collapse
end of anesthesia
number of intraoperatively FOB examinations
end of anesthesia
Glottic or tracheo-bronchial lesion
end of hospitalisation
Sore throat or hoarse voice
end of hospitalisation
Study Arms (2)
Double lumen tube without a hook
ACTIVE COMPARATORBroncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
Double lumen tube with a hook
EXPERIMENTALBroncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
Interventions
Tracheal intubation using a Double lumen tube without a hook
Eligibility Criteria
You may qualify if:
- patients scheduled for lung surgery requiring one-lung ventilation
You may not qualify if:
- pregnancy
- ASA class 4
- prevision of difficult intubation or of pulmonary aspiration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Service d'Anesthésie, Hôpital Foch
Suresnes, 92150, France
Related Publications (1)
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.
PMID: 25489763DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2009
First Posted
September 1, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2012
Study Completion
May 1, 2013
Last Updated
September 23, 2016
Record last verified: 2016-09