Double-Lumen Tube With or Without a Carinal Hook

NCT ID: NCT00969683

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-05-31

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Tracheal intubation

Intervention Type: DEVICE

Tracheal intubation using a Double lumen tube without a hook

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

Group Type: EXPERIMENTAL

Tracheal intubation

Intervention Type: DEVICE

Tracheal intubation with a Double lumen tube with a hook

Interventions

Tracheal intubation

Tracheal intubation using a Double lumen tube without a hook

Intervention Type: DEVICE

Tracheal intubation

Tracheal intubation with a Double lumen tube with a hook

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Fischler, MD

Role: STUDY_CHAIR

Hôpital Foch

Locations

Service d'Anesthésie, Hôpital Foch

Suresnes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25489763 (View on PubMed)

Other Identifiers

2009/21

Identifier Type: -

Identifier Source: org_study_id