Cardiac ArrestSLETINCT02305524
Intubation During Adult Intubation
A study testing ETView VivaSight SL and Macintosh laryngoscope in people with Cardiac Arrest, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a EMS-paramedics. 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
- What is being tested?
- ETView VivaSight SL and Macintosh laryngoscope
- 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 (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, 1 recruiting
- Recruiting
International Institute of Rescue Research and Education
Warsaw, Masovia, 04-628
Lukasz Szarpak, +48500186225, lukasz.szarpak@gmail.com
Lukasz Szarpak
About this study
Official title: Evaluation of Chest Compression Effect on Airway Management With he Visualized Tracheoscopic Ventilation Tube and the Macintosh Laryngoscopy by Novice Paramedics: a Randomized Crossover Simulation Study.
The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.
- Conditions
- Cardiac Arrest
- Being tested
- ETView VivaSight SL, Macintosh laryngoscope
- Keywords
- endotracheal 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.
ETView VivaSight SLDevice
Intubation using ETView VivaSight SL
Macintosh laryngoscopeDevice
intubation with macintosh laryngoscope with conventional tube
| Study group | Role | What they receive |
|---|---|---|
| ETI with chest compressions | Experimental | endotracheal intubation (ETI) during child mannikin 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: ETView VivaSight SL; Device: Macintosh laryngoscope |
| ETI without chest compressions | Experimental | Endotracheal intubation of child mannikin during resuscitation without chest compressions. Receives: Device: ETView VivaSight SL; Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (2)
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
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
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 posted2 Dec 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305524
- Sponsor's protocol ID
- ETI/2014/44
- Acronym
- SLETI
- Status last verified
- Nov 2014
- First submitted
- 27 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chest Compression Effect on Airway Management With he Visualized Tracheoscopic Ventilation Tube and the Macintosh Laryngoscopy by Novice Paramedics: a Randomized Crossover Simulation Study.
- ClinicalTrials.gov ID
- NCT02305524
- Acronym / sponsor ID
- SLETI / ETI/2014/44
- Conditions
- Cardiac Arrest
- Keywords
- endotracheal intubation
- 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
- 2 Dec 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 objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETI with chest compressions | Experimental | Device: ETView VivaSight SL, Device: Macintosh laryngoscopeendotracheal intubation (ETI) during child mannikin 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.). |
| ETI without chest compressions | Experimental | Device: ETView VivaSight SL, Device: Macintosh laryngoscopeEndotracheal intubation of child mannikin during resuscitation without chest compressions. |
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 (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 |
|---|---|---|
| ETView VivaSight SLIntubation using ETView VivaSight SL | Device | ETI with chest compressions, ETI without chest compressions |
| Macintosh laryngoscopeintubation with macintosh laryngoscope with conventional tube | Device | ETI with chest compressions, ETI without chest compressions |
Primary outcome
Success of intubation
Time frame: 1 day
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.
2 secondary outcomes
Time to intubation
Time frame: 1 day
Cormack-Lehan scale
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 2 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETView VivaSight SL and Macintosh laryngoscope 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 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 2 Dec 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 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 2 Dec 2014.