IntubationSLNCT02295618
ETI During Intubation
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 objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians. 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
- 107 participants
- Where
- 1 sitePoland
- Study dates
- Nov 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
- maximum 1 year of work experience in medicine
- maximum 10 clinical intubations
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: Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: 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 novice-physicians.
- 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
Intubation using Macintosh laryngoscope and standard tracheal tube
ETView VivaSight SLDevice
Intubation using ETView VivaSight SL
| 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: Standard tracheal tube; Device: ETView VivaSight SL |
| ETI without chest compressions | Experimental | Endotracheal intubation of child mannikin during resuscitation without chest compressions. 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.
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 (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 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 posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 107 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, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295618
- Sponsor's protocol ID
- ETI/2014/41
- Acronym
- SL
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.
PubMed 26020389
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
- Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: a Randomized Crossover Simulation Study.
- ClinicalTrials.gov ID
- NCT02295618
- Acronym / sponsor ID
- SL / ETI/2014/41
- Conditions
- Intubation, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- 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 objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.
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: Standard tracheal tube, Device: ETView VivaSight SLendotracheal 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: Standard tracheal tube, Device: ETView VivaSight SLEndotracheal 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
- maximum 1 year of work experience in medicine
- maximum 10 clinical intubations
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 tubeIntubation using Macintosh laryngoscope and standard tracheal tube | Device | ETI with chest compressions, ETI without chest compressions |
| ETView VivaSight SLIntubation using ETView VivaSight SL | Device | ETI with chest compressions, ETI without chest 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.
2 secondary outcomes
Success of intubation
Time frame: 1 day
Cormack-Lehan scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 26020389Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.
Related trials for Intubation
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Active, not recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
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 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT02295618, which also lists 1 linked publication.
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.