Cardiac ArrestNCT02277015
Intubation During Pediatric Resuscitation
A study testing Miller Laryngoscope, The Berci-Kaplan DCI and The AirTraq in people with Cardiac Arrest and Endotracheal Intubation, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Endotracheal Intubation, Pediatric Manikin
- What is being tested?
- Miller Laryngoscope, The Berci-Kaplan DCI and The AirTraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePoland
- Study dates
- Oct 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: Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions
The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.
- Conditions
- Cardiac Arrest, Endotracheal Intubation, Pediatric Manikin
- Being tested
- Miller Laryngoscope, The Berci-Kaplan DCI, The AirTraq, GlideScope GVL, The Pentax AWS
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller LaryngoscopeDevice
Direct Laryngoscopy
The Berci-Kaplan DCIDevice
Videolaryngoscope-1
The AirTraqDevice
Videolaryngoscope-2
GlideScope GVLDevice
Videolaryngoscope-3
The Pentax AWSDevice
Videolaryngoscope-4
| Study group | Role | What they receive |
|---|---|---|
| ETI without chest compressions | Experimental | Endotracheal intubation during pediatric resuscitation without chest compressions. Receives: Device: Miller Laryngoscope; Device: The Berci-Kaplan DCI; Device: The AirTraq; Device: GlideScope GVL; Device: The Pentax AWS |
| ETI with chest compressions | Experimental | Endotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control). Receives: Device: Miller Laryngoscope; Device: The Berci-Kaplan DCI; Device: The AirTraq; Device: GlideScope GVL; Device: The Pentax AWS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
time in seconds required for a successful intubation attempt with the five different ETI devices
Measured: 1 month
Secondary outcomes (6)
Successful intubation
effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices
Measured: 1 month
POGO score
self reported percentage og glottis opening (POGO) score
Measured: 1 month
VAS score
To assess subjective opinion about the difficulty of the procedure, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (very easy) to 5 (very difficult).
Measured: 1 month
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Measured: 1 month
First Pass Attempt
Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.
Measured: 1 month
Overall Success
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
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, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277015
- Sponsor's protocol ID
- ETI/2014/02
- Status last verified
- Oct 2014
- First submitted
- 26 Oct 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
- Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions
- ClinicalTrials.gov ID
- NCT02277015
- Acronym / sponsor ID
- ETI/2014/02
- Conditions
- Cardiac Arrest, Endotracheal Intubation, Pediatric Manikin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (estimated)
- First posted
- 28 Oct 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 European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETI without chest compressions | Experimental | Device: Miller Laryngoscope, Device: The Berci-Kaplan DCI, Device: The AirTraq, Device: GlideScope GVL, Device: The Pentax AWSEndotracheal intubation during pediatric resuscitation without chest compressions. |
| ETI with chest compressions | Experimental | Device: Miller Laryngoscope, Device: The Berci-Kaplan DCI, Device: The AirTraq, Device: GlideScope GVL, Device: The Pentax AWSEndotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control). |
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 |
|---|---|---|
| Miller LaryngoscopeDirect Laryngoscopy | Device | ETI with chest compressions, ETI without chest compressions |
| The Berci-Kaplan DCIVideolaryngoscope-1 | Device | ETI with chest compressions, ETI without chest compressions |
| The AirTraqVideolaryngoscope-2 | Device | ETI with chest compressions, ETI without chest compressions |
| GlideScope GVLVideolaryngoscope-3 | Device | ETI with chest compressions, ETI without chest compressions |
| The Pentax AWSVideolaryngoscope-4 | Device | ETI with chest compressions, ETI without chest compressions |
Primary outcome
Intubation Time
Time frame: 1 month
time in seconds required for a successful intubation attempt with the five different ETI devices
6 secondary outcomes
Successful intubation
Time frame: 1 month
POGO score
Time frame: 1 month
VAS score
Time frame: 1 month
Preferred ETI device
Time frame: 1 month
First Pass Attempt
Time frame: 1 month
Overall Success
Time frame: intraoperative
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
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miller Laryngoscope, The Berci-Kaplan DCI and The AirTraq in people with Cardiac Arrest and Endotracheal Intubation, 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 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?
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: 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.