Assessment of the the ETView Double-lumen Tube

Tracheal Intubation Clinical Trial

— ETView1  

Official title:

Assessment of the the ETView Double-lumen Tube

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02040961
• Other study ID #: 2012/64
• Secondary ID: 2012-A01552-41
• Status: Terminated
• Phase: N/A
• First received: January 16, 2014
• Last updated: October 28, 2016
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective thoracic surgery with anticipated use of a DLT

Exclusion Criteria:

• left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus

• proximal left bronchial lesion

• anatomical abnormality of the bronchial tree

• suspicion of difficult mask ventilation or intubation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• ETView Double-Lumen Tube
Tracheal intubation is performed using a ETView Double-Lumen Tube

Locations

Country	Name	City	State
France	Hopital 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	Rate of insertion	Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy	300 seconds	No
Secondary	Ease of use evaluated by the anesthesiologist	Evaluation using a score (1 = easy to use, 2 = not so easy, 3 = difficult)	3 hours	No
Secondary	Quality of lung collapse	Evaluation using a score (1 = atelectatic lung, 2 = lung well isolated but not atelectatic, 3 = failure of lung isolation)	3 hours	No
Secondary	Rate of misplacement occurring after patients removal from dorsal to lateral position		1 hour	No
Secondary	Rate of misplacement, occurring during surgery		3 hours	No
Secondary	Rate of requirement to a conventional double lumen tube	ETView Double-Lumen Tube is not well positioned. It is withdrawn and replaced by a conventional double lumen tube	3 hours	No