HealthyNCT02458534
The Comparison of Mcgrath Mac, C-MAC, and Macintosh Laryngoscope in Novice Users: a Manikin Study
A study testing Mcgrath Mac videolaryngoscope, C-MAC videolaryngoscope and macintosh laryngoscope in people with Healthy, run by Yonsei University.
Trial summary
The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for novice users in manikin. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mcgrath Mac videolaryngoscope, C-MAC videolaryngoscope and macintosh laryngoscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2015
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical students
Who cannot join
- wrist disease excluded.
About this study
The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for novice users in manikin.
- Conditions
- Healthy
- Being tested
- Mcgrath Mac videolaryngoscope, C-MAC videolaryngoscope, macintosh laryngoscope
- Keywords
- Simulated manikin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mcgrath Mac videolaryngoscopeOther
Participants perform three intubation attempts using Mcgrath Mac videolaryngoscope in the manikin with the normal airway and difficult airway settings.
C-MAC videolaryngoscopeOther
Participants perform three intubation attempts using C-MAC videolaryngoscope in the manikin with the normal airway and difficult airway settings.
macintosh laryngoscopeOther
Participants perform three intubation attempts using macintosh laryngoscope in the manikin with the normal airway and difficult airway settings.
| Study group | Role | What they receive |
|---|---|---|
| Mcgrath Mac videolaryngoscope | Experimental | Participants perform three intubation attempts using Mcgrath Mac videolaryngoscope in the manikin with the normal airway setting. Then the participants perform three intubation attempts using the manikin with difficult airway setting. Receives: Other: Mcgrath Mac videolaryngoscope |
| C-MAC videolaryngoscope | Experimental | Participants perform three intubation attempts using C-MAC videolaryngoscope in the manikin with the normal airway setting. Then the participants perform three intubation attempts using the manikin with difficult airway setting. Receives: Other: C-MAC videolaryngoscope |
| Macintosh laryngoscope | Active comparator | Participants perform three intubation attempts using macintosh laryngoscope in the manikin with the normal airway setting. Then the participants perform three intubation attempts using the manikin with difficult airway setting. Receives: Other: macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
Time to intubation is defined as the time from the insertion of the laryngoscope into the mouth of the manikin to the confirmation of the chest movement of the manikin.
Measured: within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin
Secondary outcomes (1)
success rate of the first intubation attempt
Measured: Within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458534
- Sponsor's protocol ID
- 1-2015-0020
- Status last verified
- Aug 2015
- First submitted
- 26 May 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Mcgrath Mac, C-MAC, and Macintosh Laryngoscope in Novice Users: a Manikin Study
- ClinicalTrials.gov ID
- NCT02458534
- Acronym / sponsor ID
- 1-2015-0020
- Conditions
- Healthy
- Keywords
- Simulated manikin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Jun 2015 (estimated)
- 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.
The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for novice users in manikin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mcgrath Mac videolaryngoscope | Experimental | Other: Mcgrath Mac videolaryngoscopeParticipants perform three intubation attempts using Mcgrath Mac videolaryngoscope in the manikin with the normal airway setting. Then the participants perform three intubation attempts using the manikin with difficult airway setting. |
| C-MAC videolaryngoscope | Experimental | Other: C-MAC videolaryngoscopeParticipants perform three intubation attempts using C-MAC videolaryngoscope in the manikin with the normal airway setting. Then the participants perform three intubation attempts using the manikin with difficult airway setting. |
| Macintosh laryngoscope | Active comparator | Other: macintosh laryngoscopeParticipants perform three intubation attempts using macintosh laryngoscope in the manikin with the normal airway setting. Then the participants perform three intubation attempts using the manikin with difficult airway setting. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medical students
Key exclusion criteria (1 listed)
- wrist disease excluded.
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 |
|---|---|---|
| Mcgrath Mac videolaryngoscopeParticipants perform three intubation attempts using Mcgrath Mac videolaryngoscope in the manikin with the normal airway and difficult airway settings. | Other | Mcgrath Mac videolaryngoscope |
| C-MAC videolaryngoscopeParticipants perform three intubation attempts using C-MAC videolaryngoscope in the manikin with the normal airway and difficult airway settings. | Other | C-MAC videolaryngoscope |
| macintosh laryngoscopeParticipants perform three intubation attempts using macintosh laryngoscope in the manikin with the normal airway and difficult airway settings. | Other | Macintosh laryngoscope |
Primary outcome
time to intubation
Time frame: within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin
Time to intubation is defined as the time from the insertion of the laryngoscope into the mouth of the manikin to the confirmation of the chest movement of the manikin.
1 secondary outcome
success rate of the first intubation attempt
Time frame: Within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mcgrath Mac videolaryngoscope, C-MAC videolaryngoscope and macintosh laryngoscope in people with Healthy, run by Yonsei University.
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: finished, as of the sponsor's last update on 19 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to intubation (time frame: within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin). 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 19 Aug 2015.