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Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents (MacGrathDES)

Primary Purpose

Thoracic Injuries

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
macGrath
Macintosh's
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thoracic Injuries focused on measuring Mac Grath, Double lumen tube

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thoracic Surgery
  • Insertion of double lumen tube

Exclusion Criteria:

  • 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

Sites / Locations

  • Hôpital Roger Salengro, CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mac grath group

Macintosh Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Individual Determination of Cormack Stage
scoring system for the grading of direct laryngoscopy in case of tracheal intubation is difficult
Rate of good positioning of double lumen tube confirmed by fibroscopy
The rate of patients with an increase in systolic blood pressure of more than 20% compared to the measurement before insertion of the probe
Intubation time
The rate of patients with pharyngeal pains upon awakening

Full Information

First Posted
October 10, 2018
Last Updated
November 3, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03710096
Brief Title
Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents
Acronym
MacGrathDES
Official Title
Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Injuries
Keywords
Mac Grath, Double lumen tube

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mac grath group
Arm Type
Experimental
Arm Title
Macintosh Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
macGrath
Intervention Description
in the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube
Intervention Type
Device
Intervention Name(s)
Macintosh's
Intervention Description
in the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube
Primary Outcome Measure Information:
Title
Rate of success of intubation in both groups at the first attempt
Description
the success is defined as a correct implementation of the probe endotracheal in double light by an internal of anesthesia in the 1st attempt.
Time Frame
Baseline: one session
Secondary Outcome Measure Information:
Title
Individual Determination of Cormack Stage
Description
scoring system for the grading of direct laryngoscopy in case of tracheal intubation is difficult
Time Frame
Baseline: one session
Title
Rate of good positioning of double lumen tube confirmed by fibroscopy
Time Frame
Baseline: one session
Title
The rate of patients with an increase in systolic blood pressure of more than 20% compared to the measurement before insertion of the probe
Time Frame
Baseline: one session
Title
Intubation time
Time Frame
Baseline: one session
Title
The rate of patients with pharyngeal pains upon awakening
Time Frame
Baseline: one session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thoracic Surgery Insertion of double lumen tube Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Desbordes, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHU
City
Lille
Country
France

12. IPD Sharing Statement

Learn more about this trial

Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents

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