NCT03710096

Brief Summary

The insertion of double lumen tube is difficult even more if it is a resident with no experience. we think that using videolaryngoscopes for novice ones would facilitate insertion of double lumen tube thanks to the visualization on a LCD screen of the laryngeal structure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

November 4, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

October 10, 2018

Last Update Submit

November 3, 2022

Conditions

Thoracic Injuries

Keywords

Mac GrathDouble lumen tube

Outcome Measures

Primary Outcomes (1)

  • Rate of success of intubation in both groups at the first attempt

    the success is defined as a correct implementation of the probe endotracheal in double light by an internal of anesthesia in the 1st attempt.

    Baseline: one session

Secondary Outcomes (5)

  • Individual Determination of Cormack Stage

    Baseline: one session

  • Rate of good positioning of double lumen tube confirmed by fibroscopy

    Baseline: one session

  • The rate of patients with an increase in systolic blood pressure of more than 20% compared to the measurement before insertion of the probe

    Baseline: one session

  • Intubation time

    Baseline: one session

  • The rate of patients with pharyngeal pains upon awakening

    Baseline: one session

Study Arms (2)

Mac grath group

EXPERIMENTAL
Device: macGrath

Macintosh Group

ACTIVE COMPARATOR
Device: Macintosh's

Interventions

macGrathDEVICE

in the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube

Mac grath group
Macintosh'sDEVICE

in the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube

Macintosh Group

Eligibility Criteria

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

You may qualify if:

  • Thoracic Surgery
  • Insertion of double lumen tube

You may not qualify if:

  • Emergency surgery
  • Risk of inhalation
  • Person unable to consent
  • Persons deprived of liberty, under guardianship or trusteeship
  • Pregnant or lactating woman
  • Allergy to Tracrium, Propofol, Sufentanil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jacques Desbordes, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 17, 2018

Study Start

November 4, 2018

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

FR(1)