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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03710096
Other study ID # 2017_65
Secondary ID 2018-A00789-46
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2018
Est. completion date August 8, 2019

Study information

Verified date November 2022
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date August 8, 2019
Est. primary completion date August 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
macGrath
in the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube
Macintosh's
in the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube

Locations

Country Name City State
France Hôpital Roger Salengro, CHU Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Individual Determination of Cormack Stage scoring system for the grading of direct laryngoscopy in case of tracheal intubation is difficult Baseline: one session
Secondary Rate of good positioning of double lumen tube confirmed by fibroscopy Baseline: one session
Secondary 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
Secondary Intubation time Baseline: one session
Secondary The rate of patients with pharyngeal pains upon awakening Baseline: one session
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