NCT05851664

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

April 30, 2023

Last Update Submit

May 20, 2023

Conditions

LaryngoscopyGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Time needed to intubate

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

    during the intubation

Secondary Outcomes (3)

  • Difficulty of the laryngoscopy

    at the end of intubation

  • Number of intubation attempts.

    at the end of intubation

  • Major desaturation

    during intubation

Study Arms (2)

Group Direct laryngoscopy (DL)

ACTIVE COMPARATOR

Group DL: intubated with direct laryngoscopy type Macintosh.

Device: intubation by direct laryngoscopy

Group vidéo Laryngoscopy (VL)

EXPERIMENTAL

Group VL: intubated with a video laryngoscope type McGrath

Device: Intubation by videolaryngoscopy

Interventions

intubation by direct laryngoscopyDEVICE

intubation using a direct laryngoscopy type macintosh

Also known as: DL
Group Direct laryngoscopy (DL)
Intubation by videolaryngoscopyDEVICE

Intubation using a videolaryngoscope type McGrath

Also known as: VL
Group vidéo Laryngoscopy (VL)

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years-old;
  • ASA status 1 to 3;
  • General anesthesia and intubation.

You may not qualify if:

  • Difficult intubations criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim hospital

Tunis, 2085, Tunisia

Location

Study Officials

  • Mhamed Sami MS Mebazaa, Pr

    Mongi Slim Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2023

First Posted

May 10, 2023

Study Start

January 1, 2023

Primary Completion

March 31, 2023

Study Completion

April 30, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)