Cardiac ArrestNCT02289664
Videolaryngoscopy During Child Intubation
A study testing MAC, Coopdech and CoPilot in people with Cardiac Arrest, run by International Institute of Rescue Research and Education at 1 site in Poland.
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 three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin. 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?
- MAC, Coopdech and CoPilot
- 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 Dec 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 health care
Who cannot join
- Not meet the above criteria
- Wrist or Low back diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
International Institute of Rescue Research and Education
Warsaw, Masovia, 03-122
Lukasz Szarpak, +48500186225, lukasz.szarpak@gmail.com
Lukasz Szarpak
About this study
Official title: A Comparison of Coopdech, Intubrite, and CoPilot Video-laryngoscopes With Macintosh Laryngoscope for Tracheal Intubation 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 three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.
- Conditions
- Cardiac Arrest
- Being tested
- MAC, Coopdech, CoPilot, Intubrite
- Keywords
- intubation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACDevice
Also called Macintosh Laryngoscope
Direct-Laryngoscopy
CoopdechDevice
Also called Coopdech Video Lartyngoscope Portable VLP-100
Video-Laryngoscopy -1
CoPilotDevice
Also called CoPilot Video Laryngoscope
Video-Laryngoscopy -2
IntubriteDevice
Also called Intubrite Video Laryngoscope System VLS 6600
Video-Laryngoscopy -3
| Study group | Role | What they receive |
|---|---|---|
| Intubation without chest compressions | Experimental | Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions. Receives: Device: MAC; Device: Coopdech; Device: CoPilot; Device: Intubrite |
| Intubation with uninterrupted chest compressions | Experimental | Endotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.). Receives: Device: MAC; Device: Coopdech; Device: CoPilot; Device: Intubrite |
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 each device
Measured: 1 MONTH
Secondary outcomes (3)
Intubation time
time in seconds required for a successful intubation attempt
Measured: 1 MONTH
POGO score
self-reported percentage of glottis opening (POGO) score
Measured: 1 mONTH
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Measured: 1 MONTH
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 completionDec 2014 (estimated)
- Study completionDec 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
- 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
- NCT02289664
- Sponsor's protocol ID
- ETI/2014/11
- Status last verified
- Nov 2014
- First submitted
- 10 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
- A Comparison of Coopdech, Intubrite, and CoPilot Video-laryngoscopes With Macintosh Laryngoscope for Tracheal Intubation in Pediatric Patients During Resuscitation. Randomized Crossover Manikin Trial
- ClinicalTrials.gov ID
- NCT02289664
- Acronym / sponsor ID
- ETI/2014/11
- Conditions
- Cardiac Arrest
- 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
- Dec 2014 (estimated)
- Study completion
- Dec 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 three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation without chest compressions | Experimental | Device: MAC, Device: Coopdech, Device: CoPilot, Device: IntubriteEndotracheal intubation of pediatric mannikin during resuscitation without chest compressions. |
| Intubation with uninterrupted chest compressions | Experimental | Device: MAC, Device: Coopdech, Device: CoPilot, Device: IntubriteEndotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Give voluntary consent to participate in the study
- minimum 1 year of work experience in health care
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 |
|---|---|---|
| MACAlso: Macintosh LaryngoscopeDirect-Laryngoscopy | Device | Intubation with uninterrupted chest compressions, Intubation without chest compressions |
| CoopdechAlso: Coopdech Video Lartyngoscope Portable VLP-100Video-Laryngoscopy -1 | Device | Intubation with uninterrupted chest compressions, Intubation without chest compressions |
| CoPilotAlso: CoPilot Video LaryngoscopeVideo-Laryngoscopy -2 | Device | Intubation with uninterrupted chest compressions, Intubation without chest compressions |
| IntubriteAlso: Intubrite Video Laryngoscope System VLS 6600Video-Laryngoscopy -3 | Device | Intubation with uninterrupted chest compressions, Intubation without chest compressions |
Primary outcome
Success of intubation
Time frame: 1 MONTH
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants using each device
3 secondary outcomes
Intubation time
Time frame: 1 MONTH
POGO score
Time frame: 1 mONTH
Cormack-Lehane grading
Time frame: 1 MONTH
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.
Related trials for Cardiac Arrest
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Not yet recruitingObservational study
Therapeutic Outcomes of In-Hospital Resuscitation of Patients Admitted to the Internal Medicine Wards
Survival to Discharge With Good Neurologic Outcome Among in Hospital Cardiac Arrest Patients
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 MAC, Coopdech and CoPilot in people with Cardiac Arrest, 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 2 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.
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?
Contact Andrzej Kurowski (+48500186225, andrzejkurowski987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of intubation (time frame: 1 MONTH). 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.