Endotracheal IntubationNCT02804451
Intubation During Cardiopulmonary Resuscitation
A study testing Macintosh laryngoscope, TruView EVO2 laryngoscope and TruView EVO2 PCD laryngoscope in people with Endotracheal Intubation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Macintosh laryngoscope, TruView EVO2 laryngoscope and TruView EVO2 PCD laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2015to Mar 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- had not received any training in endotracheal intubation with videolaryngoscopy before the study,
- had nursing specialization in anaesthesiology or emergency medicine,
- presented with no wrist or low back diseases or pregnancy.
Who cannot join
- not meet the above criteria.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
About this study
The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.
- Conditions
- Endotracheal Intubation
- Being tested
- Macintosh laryngoscope, TruView EVO2 laryngoscope, TruView EVO2 PCD laryngoscope, ETView SL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
Also called MAC
intubation with standard macintosh larygoscope; gold standard
TruView EVO2 laryngoscopeDevice
Also called EVO2
A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
TruView EVO2 PCD laryngoscopeDevice
Also called PCD
A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
ETView SLDevice
Also called ETView
An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Intubation without chest compression | Experimental | normal airway, without chest compression during intubation. Receives: Device: Macintosh laryngoscope; Device: TruView EVO2 laryngoscope; Device: TruView EVO2 PCD laryngoscope; Device: ETView SL |
| Intubation with uninterrupted chest compression | Experimental | normal airway, with continuous chest compressions Receives: Device: Macintosh laryngoscope; Device: TruView EVO2 laryngoscope; Device: TruView EVO2 PCD laryngoscope; Device: ETView SL |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to the first ventilation attempt
Measured: 1 day
Secondary outcomes (5)
time to visualize the larynx
Measured: 1 day
time to introduce the endotracheal tube through the vocal cords
Measured: 1 day
success rate
first intubation attempt success rate
Measured: 1 day
degree of larynx visibility
analysed based on a Cormack-Lehane scale
Measured: 1 day
ease of intubation technique
10-point visual analogue scale (VAS) was used, where 1 indicated an extremely simple procedure, while 10 - an extremely difficult one
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 posted17 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
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 Endotracheal 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
- Investigators
- Lukasz Szarpak, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804451
- Sponsor's protocol ID
- 03/02/2016
- Status last verified
- Jun 2016
- First submitted
- 11 Jun 2016
- Last updated
- 17 Jun 2016
- 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 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation During Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT02804451
- Acronym / sponsor ID
- 03/02/2016
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Jun 2016 (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 the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation without chest compression | Experimental | Device: Macintosh laryngoscope, Device: TruView EVO2 laryngoscope, Device: TruView EVO2 PCD laryngoscope, Device: ETView SLnormal airway, without chest compression during intubation. |
| Intubation with uninterrupted chest compression | Experimental | Device: Macintosh laryngoscope, Device: TruView EVO2 laryngoscope, Device: TruView EVO2 PCD laryngoscope, Device: ETView SLnormal airway, with continuous chest compressions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- had not received any training in endotracheal intubation with videolaryngoscopy before the study,
- had nursing specialization in anaesthesiology or emergency medicine,
- presented with no wrist or low back diseases or pregnancy.
Key exclusion criteria (1 listed)
- not meet the above criteria.
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 |
|---|---|---|
| Macintosh laryngoscopeAlso: MACintubation with standard macintosh larygoscope; gold standard | Device | Intubation with uninterrupted chest compression, Intubation without chest compression |
| TruView EVO2 laryngoscopeAlso: EVO2A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel), | Device | Intubation with uninterrupted chest compression, Intubation without chest compression |
| TruView EVO2 PCD laryngoscopeAlso: PCDA TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel), | Device | Intubation with uninterrupted chest compression, Intubation without chest compression |
| ETView SLAlso: ETViewAn ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube | Device | Intubation with uninterrupted chest compression, Intubation without chest compression |
Primary outcome
time to the first ventilation attempt
Time frame: 1 day
5 secondary outcomes
time to visualize the larynx
Time frame: 1 day
time to introduce the endotracheal tube through the vocal cords
Time frame: 1 day
success rate
Time frame: 1 day
degree of larynx visibility
Time frame: 1 day
ease of intubation technique
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 17 Jun 2016.
- Background: 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.
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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, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscope, TruView EVO2 laryngoscope and TruView EVO2 PCD laryngoscope in people with Endotracheal Intubation, run by Medical University of Warsaw 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 1 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 17 Jun 2016. 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 the first ventilation attempt (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 NCT02804451, 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 17 Jun 2016.