NCT02040961

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

January 16, 2014

Last Update Submit

October 28, 2016

Conditions

Tracheal Intubation

Keywords

PatientsUndergoingElectiveThoracicSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Ease of use evaluated by the anesthesiologist

    3 hours

  • Quality of lung collapse

    3 hours

  • Rate of misplacement occurring after patients removal from dorsal to lateral position

    1 hour

  • Rate of misplacement, occurring during surgery

    3 hours

  • Rate of requirement to a conventional double lumen tube

    3 hours

Study Arms (1)

EtView

EXPERIMENTAL

Use of ETVew double-lumen tube

Device: ETView Double-Lumen Tube

Interventions

ETView Double-Lumen TubeDEVICE

Tracheal intubation is performed using a ETView Double-Lumen Tube

EtView

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective thoracic surgery with anticipated use of a DLT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Study Officials

  • Virginie Dumans-Nizard, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)