TraumaNCT02292693
Direct Laryngoscopy During Cervical Trauma
A study testing MIL, MAC and McCoy in people with Trauma, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- MIL, MAC and McCoy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2014to Nov 2014
- 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
- minimum 1 year of work experience in emergency medicine
- experienced emergency medicine personnel (physicians, nurses, 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
International Institute of Rescue Research and Education
Warsaw, Masovia, 03-122
About this study
Official title: Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.
The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.
- Conditions
- Trauma
- Being tested
- MIL, MAC, McCoy
- Keywords
- intubation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILDevice
Direct laryngoscopy. Laryngoscopy with Miller blade
MACDevice
Direct laryngoscopy. Laryngoscopy with Macintosh blade
McCoyDevice
Direct laryngoscopy. Laryngoscopy with McCoy blade
| Study group | Role | What they receive |
|---|---|---|
| intubation with immobilized cervical spine | Experimental | endotracheal intubation with immobilized cervical spine Receives: Device: MIL; Device: MAC; Device: McCoy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of intubation
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
Measured: 1 day
Secondary outcomes (3)
Intubation time
time in seconds required for a successful intubation attempt
Measured: 1 day
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Measured: 1 day
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Rescue Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Szarpak, National Institute of Cardiology, Warsaw, Poland
- Investigators
- Lukasz Szarpak, Principal investigator, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292693
- Sponsor's protocol ID
- ETI/2014/18
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.
- ClinicalTrials.gov ID
- NCT02292693
- Acronym / sponsor ID
- ETI/2014/18
- Conditions
- Trauma
- Keywords
- intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 17 Nov 2014 (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 aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intubation with immobilized cervical spine | Experimental | Device: MIL, Device: MAC, Device: McCoyendotracheal intubation with immobilized cervical spine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- give voluntary consent to participate in the study
- minimum 1 year of work experience in emergency medicine
- experienced emergency medicine personnel (physicians, nurses, 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 |
|---|---|---|
| MILDirect laryngoscopy. Laryngoscopy with Miller blade | Device | intubation with immobilized cervical spine |
| MACDirect laryngoscopy. Laryngoscopy with Macintosh blade | Device | intubation with immobilized cervical spine |
| McCoyDirect laryngoscopy. Laryngoscopy with McCoy blade | Device | intubation with immobilized cervical spine |
Primary outcome
Success of intubation
Time frame: 1 day
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
3 secondary outcomes
Intubation time
Time frame: 1 day
Cormack-Lehane grading
Time frame: 1 day
Preferred ETI device
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
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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.
Lukasz Szarpak principal investigator
Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIL, MAC and McCoy in people with Trauma, run by International Institute of Rescue Research and Education 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 3 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: status not confirmed, as of the sponsor's last update on 17 Nov 2014. 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?
Results are not available in the source record.
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?
Success of 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 17 Nov 2014.