Double-Lumen Tube With or Without a Carinal Hook

Anesthesia Clinical Trial

Official title:

Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969683
• Other study ID #: 2009/21
• Status: Completed
• Phase: N/A
• First received: August 28, 2009
• Last updated: September 22, 2016
• Start date: August 2009
• Est. completion date: May 2013

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Tracheal intubation
Tracheal intubation using a Double lumen tube without a hook
• Tracheal intubation
Tracheal intubation with a Double lumen tube with a hook

Locations

Country	Name	City	State
France	Service d'Anesthésie, Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time required to initially position the assigned tube		end of anesthesia	No
Secondary	degree of lung collapse		end of anesthesia	No
Secondary	number of intraoperatively FOB examinations		end of anesthesia	No
Secondary	Glottic or tracheo-bronchial lesion		end of hospitalisation	No
Secondary	Sore throat or hoarse voice		end of hospitalisation	No