IntubationPIDRNCT02277405
Pediatric Intubation During Resuscitation
A study testing Shikani Optical Stylet and Endoeye Flexible Intubation (LF-V) in people with Intubation and Resuscitation, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with 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
- Intubation, Resuscitation
- What is being tested?
- Shikani Optical Stylet and Endoeye Flexible Intubation (LF-V)
- 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
- 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 medical personnel (paramedics, nurses, physicians)
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, (+48)500186225, lukasz.szarpak@gmail.com
About this study
Official title: A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation
The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.
Read the detailed description
Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.
- Conditions
- Intubation, Resuscitation
- Being tested
- Shikani Optical Stylet, Endoeye Flexible Intubation (LF-V)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shikani Optical StyletDevice
Optical intubation
Endoeye Flexible Intubation (LF-V)Device
endoscopy intubation
| Study group | Role | What they receive |
|---|---|---|
| Intubation without chest compressions | Experimental | Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions. Receives: Device: Shikani Optical Stylet; Device: Endoeye Flexible Intubation (LF-V) |
| 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: Shikani Optical Stylet; Device: Endoeye Flexible Intubation (LF-V) |
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 month
Secondary outcomes (2)
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 month
VAS score
participants were asked which method they would prefer in a real-life resuscitation.
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 posted29 Oct 2014 (estimated)
- Study startOct 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 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
- Single blind
- Who is masked
- Outcomes assessor
- 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, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277405
- Sponsor's protocol ID
- ETI/2014/04
- Acronym
- PIDR
- Status last verified
- Oct 2014
- First submitted
- 27 Oct 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation
- ClinicalTrials.gov ID
- NCT02277405
- Acronym / sponsor ID
- PIDR / ETI/2014/04
- Conditions
- Intubation, Resuscitation
- 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
- Oct 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 29 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 aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.
Detailed description
Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation without chest compressions | Experimental | Device: Shikani Optical Stylet, Device: Endoeye Flexible Intubation (LF-V)Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions. |
| Intubation with uninterrupted chest compressions | Experimental | Device: Shikani Optical Stylet, Device: Endoeye Flexible Intubation (LF-V)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.). |
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 (paramedics, nurses, physicians)
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 |
|---|---|---|
| Shikani Optical StyletOptical intubation | Device | Intubation with uninterrupted chest compressions, Intubation without chest compressions |
| Endoeye Flexible Intubation (LF-V)endoscopy intubation | Device | Intubation with uninterrupted chest compressions, Intubation without chest compressions |
Primary outcome
Time to intubation
Time frame: 1 month
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.
2 secondary outcomes
Success of intubation
Time frame: 1 month
VAS score
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 29 Oct 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 Shikani Optical Stylet and Endoeye Flexible Intubation (LF-V) in people with Intubation and Resuscitation, 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 29 Oct 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 Lukasz Czyzewski (+48696457655, czyzewski_lukasz@wp.pl), 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 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 29 Oct 2014.