Assessment of the the ETView Double-lumen Tube

Not Applicable

Terminated

• Conditions: Tracheal Intubation
• Interventions: Device: ETView Double-Lumen Tube

• Registration Number: NCT02040961
• Lead Sponsor: Hopital Foch

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• elective thoracic surgery with anticipated use of a DLT

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EtView	ETView Double-Lumen Tube	Use of ETVew double-lumen tube

Primary Outcome Measures

Name	Time	Method
Rate of insertion	300 seconds	Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy

Secondary Outcome Measures

Name	Time	Method
Ease of use evaluated by the anesthesiologist	3 hours	Evaluation using a score (1 = easy to use, 2 = not so easy, 3 = difficult)
Rate of misplacement occurring after patients removal from dorsal to lateral position	1 hour
Rate of misplacement, occurring during surgery	3 hours
Quality of lung collapse	3 hours	Evaluation using a score (1 = atelectatic lung, 2 = lung well isolated but not atelectatic, 3 = failure of lung isolation)
Rate of requirement to a conventional double lumen tube	3 hours	ETView Double-Lumen Tube is not well positioned. It is withdrawn and replaced by a conventional double lumen tube

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France