IntubationNCT02295631
ETI During Spinal Trauma
A study testing Standard tracheal tube and ETView VivaSight SL in people with Intubation and Cardiac Arrest, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized 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, Cardiac Arrest
- What is being tested?
- Standard tracheal tube and ETView VivaSight SL
- 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 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, 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 Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.
The aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.
- Conditions
- Intubation, Cardiac Arrest
- Being tested
- Standard tracheal tube, ETView VivaSight SL
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard tracheal tubeDevice
ETI with standard tracheal tube and Macintosh laryngoscope
ETView VivaSight SLDevice
ETI with ETView VivaSight SL
| Study group | Role | What they receive |
|---|---|---|
| ETI during immobilized spine (oral intubation) | Experimental | intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine Receives: Device: Standard tracheal tube; Device: ETView VivaSight SL |
| ETI during immobilized spine (nasal intubation) | Experimental | intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine Receives: Device: Standard tracheal tube; Device: ETView VivaSight SL |
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
Measured: 1 day
Secondary outcomes (3)
Intubation time
time in seconds required for a successful intubation attempt
Measured: 1 day
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Measured: 1 day
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295631
- Sponsor's protocol ID
- ETI/2014/42
- Status last verified
- Nov 2014
- First submitted
- 18 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
- A Comparison of Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.
- ClinicalTrials.gov ID
- NCT02295631
- Acronym / sponsor ID
- ETI/2014/42
- 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
- 20 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 aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETI during immobilized spine (oral intubation) | Experimental | Device: Standard tracheal tube, Device: ETView VivaSight SLintubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine |
| ETI during immobilized spine (nasal intubation) | Experimental | Device: Standard tracheal tube, Device: ETView VivaSight SLintubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine |
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 |
|---|---|---|
| Standard tracheal tubeETI with standard tracheal tube and Macintosh laryngoscope | Device | ETI during immobilized spine (nasal intubation), ETI during immobilized spine (oral intubation) |
| ETView VivaSight SLETI with ETView VivaSight SL | Device | ETI during immobilized spine (nasal intubation), ETI during immobilized spine (oral intubation) |
Primary outcome
Success of intubation
Time frame: 1 day
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
3 secondary outcomes
Intubation time
Time frame: 1 day
Cormack-Lehane grading
Time frame: 1 day
Preferred ETI device
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 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 Standard tracheal tube and ETView VivaSight SL 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 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.