Assessment of the the ETView Double-lumen Tube | NCT02040961

Studies
Assessment of the the ETView Double-lumen Tube

NCT02040961

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Oct 31, 2016Estimated

Enrollment

84Actual

Phase

Not Applicable

Conditions

Tracheal Intubation

Interventions

ETView Double-Lumen Tube

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A01552-41	Other Identifier	ANSM

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

An incident, burned tube, happened before intubation. The promoter decided to stop the study.

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Jan 17, 2014

First Posted Date

Jan 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EtView	Experimental	Use of ETVew double-lumen tube	Device: ETView Double-Lumen Tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ETView Double-Lumen Tube	Device	Tracheal intubation is performed using a ETView Double-Lumen Tube	EtView

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Ease of use evaluated by the anesthesiologist	Evaluation using a score (1 = easy to use, 2 = not so easy, 3 = difficult)	3 hours
Quality of lung collapse	Evaluation using a score (1 = atelectatic lung, 2 = lung well isolated but not atelectatic, 3 = failure of lung isolation)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virginie Dumans-Nizard, MD	Hôpital Foch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Foch		Suresnes		92150	France