Assessment of the the ETView Double-lumen Tube (ETView1)

October 28, 2016 updated by: Hopital Foch
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EtView
Use of ETVew double-lumen tube
Device: ETView Double-Lumen Tube
Tracheal intubation is performed using a ETView Double-Lumen Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of insertion
Time Frame: 300 seconds
Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy
300 seconds

Secondary Outcome Measures

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 It is withdrawn and replaced by a conventional double lumen tube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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Virginie Dumans-Nizard, MD, Hôpital FOCH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/64
  • 2012-A01552-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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