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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Injuries
• Intervention / Treatment: Device: macGrath; Device: Macintosh's

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mac grath group	Device: macGrath; in the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube
Active Comparator: Macintosh Group	Device: Macintosh's; in the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual Determination of Cormack Stage	scoring system for the grading of direct laryngoscopy in case of tracheal intubation is difficult	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Jacques Desbordes, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2018
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Double lumen tube; Mac Grath
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries
• Other Study ID Numbers: 2017_65; 2018-A00789-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No