Endotracheal IntubationNCT02681835
Endotracheal Intubation in Prehospital Scenario
A study testing C-MAC laryngoscope and Macintosh laryngoscope in people with Endotracheal Intubation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- C-MAC laryngoscope and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Mar 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- minimum 50 clinical intubations
- paramedics
Who cannot join
- not meet the above criteria
- wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
About this study
Official title: Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial
We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.
- Conditions
- Endotracheal Intubation
- Being tested
- C-MAC laryngoscope, Macintosh laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC laryngoscopeDevice
Also called C-MAC
Intubation performed using C-MAC laryngoscope
Macintosh laryngoscopeDevice
Also called C-MAC
Intubation performed using laryngoscope with Macintosh blade
| Study group | Role | What they receive |
|---|---|---|
| Position 1 | Experimental | Standard position during intubation. Intubator is behind head of the victim, propped up on both elbows Receives: Device: C-MAC laryngoscope; Device: Macintosh laryngoscope |
| Position 2 | Experimental | Intubator is behind head of the victim, lies on the left side Receives: Device: C-MAC laryngoscope; Device: Macintosh laryngoscope |
| Position 3 | Experimental | Intubator stands astride the victims, intubated using the face-to-face Receives: Device: C-MAC laryngoscope; Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for successful intubation
Measured: 1 day
Secondary outcomes (5)
success rate of intubation attempt
success rate of first, second and third intubation attempt
Measured: 1 day
cumulative success ratios related to time
cumulative success ratio was counted as percentage of successful intubations in time intervals in all scenarios
Measured: 1 day
Ease of intubation
To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
Measured: 1 day
Cormack&Lehane grade
glottic view during intubation rate using Cormack\&Lehane grade
Measured: 1 day
Dental Compression
the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681835
- Sponsor's protocol ID
- 02.007.1MR
- Status last verified
- Mar 2016
- First submitted
- 10 Feb 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial
- ClinicalTrials.gov ID
- NCT02681835
- Acronym / sponsor ID
- 02.007.1MR
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Feb 2016 (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.
We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Position 1 | Experimental | Device: C-MAC laryngoscope, Device: Macintosh laryngoscopeStandard position during intubation. Intubator is behind head of the victim, propped up on both elbows |
| Position 2 | Experimental | Device: C-MAC laryngoscope, Device: Macintosh laryngoscopeIntubator is behind head of the victim, lies on the left side |
| Position 3 | Experimental | Device: C-MAC laryngoscope, Device: Macintosh laryngoscopeIntubator stands astride the victims, intubated using the face-to-face |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- minimum 50 clinical intubations
- paramedics
Key exclusion criteria (2 listed)
- not meet the above criteria
- wrist or low back diseases
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 |
|---|---|---|
| C-MAC laryngoscopeAlso: C-MACIntubation performed using C-MAC laryngoscope | Device | Position 1, Position 2, Position 3 |
| Macintosh laryngoscopeAlso: C-MACIntubation performed using laryngoscope with Macintosh blade | Device | Position 1, Position 2, Position 3 |
Primary outcome
Time required for successful intubation
Time frame: 1 day
5 secondary outcomes
success rate of intubation attempt
Time frame: 1 day
cumulative success ratios related to time
Time frame: 1 day
Ease of intubation
Time frame: 1 day
Cormack&Lehane grade
Time frame: 1 day
Dental Compression
Time frame: 1 day
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 9 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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 C-MAC laryngoscope and Macintosh laryngoscope in people with Endotracheal Intubation, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 2 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 9 Mar 2016. 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 Poland. 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?
Time required for successful intubation (time frame: 1 day). 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 Mar 2016.