IntubationNURS_ETINCT02294916
Pediatric Intubation by Nurses
A study testing AWS, Intubrite and AirTraq in people with Intubation and Cardiac Arrest, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Cardiac Arrest
- What is being tested?
- AWS, Intubrite and AirTraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 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 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 medical personnel - nurses
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: Comparison of Pentax-AWS Airwayscope, Intubrite, AirTraq and Miller Laryngoscope for Tracheal Intubation by Nurses During Chest Compression in a Pediatric Manikin: A Randomised Crossover Trial.
The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions.
Read the detailed description
Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.
- Conditions
- Intubation, Cardiac Arrest
- Being tested
- AWS, Intubrite, AirTraq, MIL
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWSDevice
Also called Pentax AWS
Video-laryngoscopy 1
IntubriteDevice
Also called Intubrite Video Laryngoscope System VLS 6600
Video-laryngoscopy 2
AirTraqDevice
Also called AirTraq Optical Laryngoscope
Optical-laryngoscopy
MILDevice
Also called Miller Laryngoscope
Direct-laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Child ETI withoutchest compressions | Experimental | Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions. Receives: Device: AWS; Device: Intubrite; Device: AirTraq; Device: MIL |
| Child ETI with chest compressions | Experimental | Endotracheal intubation of 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: AWS; Device: Intubrite; Device: AirTraq; Device: MIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.
Measured: 1 day
Secondary outcomes (3)
Success of intubation
effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.
Measured: 1 day
VAS score
participants were asked which method they would prefer in a real-life resuscitation.
Measured: 1 day
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 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 IntubationStudies 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
- 150 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
- NCT02294916
- Sponsor's protocol ID
- ETI/2014/25
- Acronym
- NURS_ETI
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pentax-AWS Airwayscope, Intubrite, AirTraq and Miller Laryngoscope for Tracheal Intubation by Nurses During Chest Compression in a Pediatric Manikin: A Randomised Crossover Trial.
- ClinicalTrials.gov ID
- NCT02294916
- Acronym / sponsor ID
- NURS_ETI / ETI/2014/25
- Conditions
- Intubation, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 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
- 19 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 purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions.
Detailed description
Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child ETI withoutchest compressions | Experimental | Device: AWS, Device: Intubrite, Device: AirTraq, Device: MILEndotracheal intubation of pediatric mannikin during resuscitation without chest compressions. |
| Child ETI with chest compressions | Experimental | Device: AWS, Device: Intubrite, Device: AirTraq, Device: MILEndotracheal intubation of 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 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 medical personnel - nurses
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 |
|---|---|---|
| AWSAlso: Pentax AWSVideo-laryngoscopy 1 | Device | Child ETI with chest compressions, Child ETI withoutchest compressions |
| IntubriteAlso: Intubrite Video Laryngoscope System VLS 6600Video-laryngoscopy 2 | Device | Child ETI with chest compressions, Child ETI withoutchest compressions |
| AirTraqAlso: AirTraq Optical LaryngoscopeOptical-laryngoscopy | Device | Child ETI with chest compressions, Child ETI withoutchest compressions |
| MILAlso: Miller LaryngoscopeDirect-laryngoscopy | Device | Child ETI with chest compressions, Child ETI withoutchest compressions |
Primary outcome
Time to intubation
Time frame: 1 day
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.
3 secondary outcomes
Success of intubation
Time frame: 1 day
VAS score
Time frame: 1 day
Cormack-Lehan scale
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 19 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 AWS, Intubrite and AirTraq in people with Intubation and 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 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 19 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?
Time to 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 19 Nov 2014.