IntubationNCT03161730
Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in Manikin by Novice
A study testing McGrath videolaryngoscopy, Pentax videolaryngoscopy and Macintosh laryngoscopy in people with Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the intubation time and success rate between videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice airway managers. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- McGrath videolaryngoscopy, Pentax videolaryngoscopy and Macintosh laryngoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2017to 21 Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- nurse without experience in tracheal intubation
Who cannot join
- refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in a Normal and Cervical Immobilized Manikin by Novice
The purpose of this study is to compare the intubation time and success rate between videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice airway managers.
- Conditions
- Intubation
- Being tested
- McGrath videolaryngoscopy, Pentax videolaryngoscopy, Macintosh laryngoscopy
- Keywords
- videolaryngoscope, novice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath videolaryngoscopyOther
Participants perform three intubation attempts using McGrath videolaryngoscope in the normal and cervical immobilized manikin by novice
Pentax videolaryngoscopyOther
Participants perform three intubation attempts using Pentax Airway Scope in the normal and cervical immobilized manikin by novice
Macintosh laryngoscopyOther
Participants perform three intubation attempts using Macintosh laryngoscope in the normal and cervical immobilized manikin by novice
| Study group | Role | What they receive |
|---|---|---|
| McGrath videolaryngoscopy | Experimental | Participants attempt to perform three intubation using McGrath videolaryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. Receives: Other: McGrath videolaryngoscopy |
| Pentax videolaryngoscopy | Experimental | Participants attempt to perform three intubation using Pentax videolaryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. Receives: Other: Pentax videolaryngoscopy |
| Macintosh laryngoscopy | Active comparator | Participants attempt to perform three intubation using Macintosh laryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. Receives: Other: Macintosh laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
time the blade passed the manikin's tooth until lung expansion with resuscitation bag
Measured: within 2 min after insertion of laryngoscope into manikin's mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start25 May 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161730
- Sponsor's protocol ID
- AJIRB-MED-DE4-17-026
- Status last verified
- Jan 2018
- First submitted
- 17 May 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yi IK, Kwak HJ, Lee KC, Lee JH, Min SK, Kim JY. Comparison of McGrath, Pentax, and Macintosh laryngoscope in normal and cervical immobilized manikin by novices: a randomized crossover trial. Eur J Med Res. 2020 Aug 20;25(1):35. doi: 10.1186/s40001-020-00435-0.
PubMed 32819444
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in a Normal and Cervical Immobilized Manikin by Novice
- ClinicalTrials.gov ID
- NCT03161730
- Acronym / sponsor ID
- AJIRB-MED-DE4-17-026
- Conditions
- Intubation
- Keywords
- videolaryngoscope, novice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 22 May 2017 (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.
The purpose of this study is to compare the intubation time and success rate between videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice airway managers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| McGrath videolaryngoscopy | Experimental | Other: McGrath videolaryngoscopyParticipants attempt to perform three intubation using McGrath videolaryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. |
| Pentax videolaryngoscopy | Experimental | Other: Pentax videolaryngoscopyParticipants attempt to perform three intubation using Pentax videolaryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. |
| Macintosh laryngoscopy | Active comparator | Other: Macintosh laryngoscopyParticipants attempt to perform three intubation using Macintosh laryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- nurse without experience in tracheal intubation
Key exclusion criteria (1 listed)
- refusal to consent
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 videolaryngoscopyParticipants perform three intubation attempts using McGrath videolaryngoscope in the normal and cervical immobilized manikin by novice | Other | McGrath videolaryngoscopy |
| Pentax videolaryngoscopyParticipants perform three intubation attempts using Pentax Airway Scope in the normal and cervical immobilized manikin by novice | Other | Pentax videolaryngoscopy |
| Macintosh laryngoscopyParticipants perform three intubation attempts using Macintosh laryngoscope in the normal and cervical immobilized manikin by novice | Other | Macintosh laryngoscopy |
Primary outcome
intubation time
Time frame: within 2 min after insertion of laryngoscope into manikin's mouth
time the blade passed the manikin's tooth until lung expansion with resuscitation bag
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 10 Jan 2018.
- Derived from this study: PubMed 32819444Yi IK, Kwak HJ, Lee KC, Lee JH, Min SK, Kim JY. Comparison of McGrath, Pentax, and Macintosh laryngoscope in normal and cervical immobilized manikin by novices: a randomized crossover trial. Eur J Med Res. 2020 Aug 20;25(1):35. doi: 10.1186/s40001-020-00435-0.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGrath videolaryngoscopy, Pentax videolaryngoscopy and Macintosh laryngoscopy in people with Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
intubation time (time frame: within 2 min after insertion of laryngoscope into manikin's mouth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161730, which also lists 1 linked publication.
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 10 Jan 2018.