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Do we Intubate Faster With the Videolaryngoscope?

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05851664
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
25.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.

This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.

Condition or Disease Intervention/Treatment Phase
  • Device: intubation by direct laryngoscopy
  • Device: Intubation by videolaryngoscopy
 N/A

Detailed Description

Intubation on full stomach is at high risk of pulmonary suction. It must be quick, as this risk increases with the time needed to intubate. Videolaryngoscope (VL) is recommended in case of difficult airway. Yet, its interest in full stomach remains unclear, as the time needed to intubate with a VL is variable in literature. The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.

This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Do we Intubate Faster With the Videolaryngoscope?
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Mar 31, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Group A: intubated with direct laryngoscopy type Macintosh.

Device: intubation by direct laryngoscopy
intubation using a direct laryngoscopy type macintosh
Other Names:
  • DL

    		•
    Experimental: Group B

    Group B: intubated with a video laryngoscope type McGrath

    Device: Intubation by videolaryngoscopy
    Intubation using a videolaryngoscope type McGrath
    Other Names:
  • VL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time needed to intubate [during the intubation]

      Time needed to the operator to pass the tube through vocal cords in seconds

    Secondary Outcome Measures

    1. Difficulty of the laryngoscopy [at the end of intubation]

      cormack anf lehane grade

    2. Number of intubation attempts. [at the end of intubation]

      number of attempts needed to intubate

    3. Major desaturation [during intubation]

      an oximetry under 90 %

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age > 18 years-old. ASA status 1 to 3. General anesthesia and intubation.
    Exclusion Criteria:
    • Difficult intubations criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mongi Slim hospital Tunis Tunisia 2085

    Sponsors and Collaborators

    • Mongi Slim Hospital

    Investigators

    • Principal Investigator: Mhamed Sami MS Mebazaa, Pr, Mongi Slim Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mhamed Sami Mebazaa, Professor, Mongi Slim Hospital
    ClinicalTrials.gov Identifier:
    NCT05851664
    Other Study ID Numbers:
    • Time to intubate VL
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 10, 2023