NCT04956913

Brief Summary

In this comparative prospective study, we aim to compare the classic Macintosh laryngoscope and the Mac Grath videolaryncoscope in ICU covid 19 patients recruiting intubation and invasive mechanical ventilation. patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh. we collected anthropometric and intubation data among all patients, and the 2 groups were compared regarding the time for intubation, the need of alternative techniques to intubate and the impact on the oxygenation by recording the lowest SPO2.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 8, 2021

Last Update Submit

July 8, 2021

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

Tracheal intubationmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Time for tracheal intubation

    Time from the blade pass the lips until the first breath was administred

    10 minutes

Study Arms (2)

Mac Grath

Patients of this group were intubated using Mac Gath videolaryngoscope

Device: Mac Grath

Machintosh

Patients of this group were intubated using the classic Macintosh laryngscoscope

Device: Macintosh

Interventions

Mac GrathDEVICE

Patients of this group were intubated using Mac Gath videolaryngoscope

Mac Grath
MacintoshDEVICE

Patients of this group were intubated using the Macintosh Laryngoscope

Machintosh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU covid 19 patients requiring tracheal intubation

You may qualify if:

  • All COVID 19 hypoxemic patients requiring tracheal intubation

You may not qualify if:

  • hypoxemic cardiac arrest before intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mhamed Mebazaa, Professor

CONTACT

0021622252589msmebazaa@gmail.com

Asma Ben Souissi, asso prof

CONTACT

0021698336883bsouissiasma@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of anesthesia and intensive care department

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 9, 2021

Study Start

August 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

July 9, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share