Cardiac ArrestETICPRNCT02289677
Pediatric Intubation During CPR
A study testing ATMOS Scope, COOPDECH and AirTraq in people with Cardiac Arrest, run by International Institute of Rescue Research and Education.
Trial summary
We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of two video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible Videoendoscope: ATMOS Scope) and optical-laryngoscope (the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- ATMOS Scope, COOPDECH and AirTraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- 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 years and older
- 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 medical personnel (physicians, nurses, paramedics)
Who cannot join
- Not meet the above criteria
- Wrist or Low back diseases
About this study
Official title: Comparison of the Atmos Scope, the Coopdech and the AirTraq in Pediatric Patients During Resuscitation. Randomized Crossover Manikin Trial
We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of two video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with uninterrupted chest compressions using an child manikin.
- Conditions
- Cardiac Arrest
- Being tested
- ATMOS Scope, COOPDECH, AirTraq
- Keywords
- intubation, child, resuscitation, simulation, Endotracheal
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATMOS ScopeDevice
Also called ATMOS Scope Flexible Videoendoscope
Video-laryngoscopy 1
COOPDECHDevice
Also called COOPDECH Video Laryngoscope Portable VLP-100
Video-laryngoscopy-1
AirTraqDevice
Optical-laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Intubation during chest compression | Experimental | Intubation during mannequin chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control, Redmond, WA, USA). Receives: Device: ATMOS Scope; Device: COOPDECH; Device: AirTraq |
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 using two intubation devices
Measured: 1 day
Secondary outcomes (3)
Intubation time
time in seconds required for a successful intubation attempt
Measured: 1 day
POGO score
self-reported percentage of glottis opening (POGO) score
Measured: 1 day
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
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 posted13 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 Cardiac ArrestStudies 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
- 100 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
- NCT02289677
- Sponsor's protocol ID
- ETI/2014/10
- Acronym
- ETICPR
- Status last verified
- Nov 2014
- First submitted
- 9 Nov 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Atmos Scope, the Coopdech and the AirTraq in Pediatric Patients During Resuscitation. Randomized Crossover Manikin Trial
- ClinicalTrials.gov ID
- NCT02289677
- Acronym / sponsor ID
- ETICPR / ETI/2014/10
- Conditions
- Cardiac Arrest
- Keywords
- intubation, child, resuscitation, simulation, Endotracheal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 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
- 13 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.
We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of two video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with uninterrupted chest compressions using an child manikin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubation during chest compression | Experimental | Device: ATMOS Scope, Device: COOPDECH, Device: AirTraqIntubation during mannequin chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control, Redmond, WA, USA). |
Who may qualify
- Ages
- 18 years and older
- 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 medical 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 |
|---|---|---|
| ATMOS ScopeAlso: ATMOS Scope Flexible VideoendoscopeVideo-laryngoscopy 1 | Device | Intubation during chest compression |
| COOPDECHAlso: COOPDECH Video Laryngoscope Portable VLP-100Video-laryngoscopy-1 | Device | Intubation during chest compression |
| AirTraqOptical-laryngoscopy | Device | Intubation during chest compression |
Primary outcome
Success of intubation
Time frame: 1 day
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants using two intubation devices
3 secondary outcomes
Intubation time
Time frame: 1 day
POGO score
Time frame: 1 day
Cormack-Lehane grading
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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
Questions about this trial
What is this clinical trial studying?
A study testing ATMOS Scope, COOPDECH and AirTraq in people with Cardiac Arrest, run by International Institute of Rescue Research and Education.
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 13 Nov 2014. 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?
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 13 Nov 2014.