COVID-19 Acute Respiratory Distress SyndromeNCT04956913
Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hypoxemic ICU Patients
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Mongi Slim Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Mac Grath and Macintosh
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU covid 19 patients requiring tracheal intubation
Who may be able to join
- All COVID 19 hypoxemic patients requiring tracheal intubation
Who cannot join
- hypoxemic cardiac arrest before intubation
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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.
All hypoxemic COVID19 patients requiring intubation were enrolled in this trial.
all patients had a preoxygenation with non invasive ventilation with 100% oxygen.
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.
- Being tested
- Mac Grath, Macintosh
- Keywords
- Tracheal intubation, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mac GrathDevice
Patients of this group were intubated using Mac Gath videolaryngoscope
MacintoshDevice
Patients of this group were intubated using the Macintosh Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Mac Grath | Patients of this group were intubated using Mac Gath videolaryngoscope Receives: Device: Mac Grath | |
| Machintosh | Patients of this group were intubated using the classic Macintosh laryngscoscope Receives: Device: Macintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for tracheal intubation
Time from the blade pass the lips until the first breath was administred
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956913
- Sponsor's protocol ID
- macintosh versus Mac Grath
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hypoxemic ICU Patients
- ClinicalTrials.gov ID
- NCT04956913
- Acronym / sponsor ID
- macintosh versus Mac Grath
- Keywords
- Tracheal intubation, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
All hypoxemic COVID19 patients requiring intubation were enrolled in this trial.
all patients had a preoxygenation with non invasive ventilation with 100% oxygen.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mac Grath | – | Device: Mac GrathPatients of this group were intubated using Mac Gath videolaryngoscope |
| Machintosh | – | Device: MacintoshPatients of this group were intubated using the classic Macintosh laryngscoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU covid 19 patients requiring tracheal intubation
Key inclusion criteria (1 listed)
- All COVID 19 hypoxemic patients requiring tracheal intubation
Key exclusion criteria (1 listed)
- hypoxemic cardiac arrest before intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mac GrathPatients of this group were intubated using Mac Gath videolaryngoscope | Device | Mac Grath |
| MacintoshPatients of this group were intubated using the Macintosh Laryngoscope | Device | Machintosh |
Primary outcome
Time for tracheal intubation
Time frame: 10 minutes
Time from the blade pass the lips until the first breath was administred
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Mongi Slim Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Mebazaa, Professor (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for tracheal intubation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.