IntubationETICPRNCT02289872
Pediatric Intubation
A study testing Macintosh Laryngoscope and TruView PCD Video laryngoscope 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 the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios 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?
- Macintosh Laryngoscope and TruView PCD Video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 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
- inexperienced in pediatric intubation paramedics
Who cannot join
- not meet the above criteria
- participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience
Trial locations and contacts
1 site in 1 country.
Poland1 site
International Institute of Rescue Research and Education
Warsaw, Masovie, 03-122
About this study
Official title: Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.
The aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.
- Conditions
- Intubation, Cardiac Arrest
- Being tested
- Macintosh Laryngoscope, TruView PCD Video laryngoscope
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh LaryngoscopeDevice
Direct-Laryngoscopy
TruView PCD Video laryngoscopeDevice
Video-Laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Scenario A | Experimental | The control scenario, where neither chest compression nor cervical stabilization was applied during intubation. Receives: Device: Macintosh Laryngoscope; Device: TruView PCD Video laryngoscope |
| Scenario B | Experimental | The chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA). Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures. Receives: Device: Macintosh Laryngoscope; Device: TruView PCD Video laryngoscope |
| Scenario C | Experimental | The chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied. A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine. Receives: Device: Macintosh Laryngoscope; Device: TruView PCD Video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs
Measured: 1 day
Secondary outcomes (4)
Success of intubation
success of the intubation attempt (i.e. tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators.
Measured: 1 day
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
Measured: 1 day
Dental compression
dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3).
Measured: 1day
Ease of intubation (VAS)
To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
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 posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 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
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289872
- Sponsor's protocol ID
- TruView/01
- Acronym
- ETICPR
- Status last verified
- Jan 2015
- First submitted
- 7 Nov 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szarpak L, Czyzewski L, Kurowski A, Truszewski Z. Comparison of the TruView PCD video laryngoscope and macintosh laryngoscope for pediatric tracheal intubation by novice paramedics: a randomized crossover simulation trial. Eur J Pediatr. 2015 Oct;174(10):1325-32. doi: 10.1007/s00431-015-2538-0. Epub 2015 Apr 18.
PubMed 25894914
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.
- ClinicalTrials.gov ID
- NCT02289872
- Acronym / sponsor ID
- ETICPR / TruView/01
- Conditions
- Intubation, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 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 the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scenario A | Experimental | Device: Macintosh Laryngoscope, Device: TruView PCD Video laryngoscopeThe control scenario, where neither chest compression nor cervical stabilization was applied during intubation. |
| Scenario B | Experimental | Device: Macintosh Laryngoscope, Device: TruView PCD Video laryngoscopeThe chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA). Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures. |
| Scenario C | Experimental | Device: Macintosh Laryngoscope, Device: TruView PCD Video laryngoscopeThe chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied. A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- give voluntary consent to participate in the study
- inexperienced in pediatric intubation paramedics
Key exclusion criteria (2 listed)
- not meet the above criteria
- participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience
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 LaryngoscopeDirect-Laryngoscopy | Device | Scenario A, Scenario B, Scenario C |
| TruView PCD Video laryngoscopeVideo-Laryngoscopy | Device | Scenario A, Scenario B, Scenario C |
Primary outcome
Time to intubation
Time frame: 1 day
the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs
4 secondary outcomes
Success of intubation
Time frame: 1 day
Cormack-Lehan scale
Time frame: 1 day
Dental compression
Time frame: 1day
Ease of intubation (VAS)
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 26 Jan 2015.
- Derived from this study: PubMed 25894914Szarpak L, Czyzewski L, Kurowski A, Truszewski Z. Comparison of the TruView PCD video laryngoscope and macintosh laryngoscope for pediatric tracheal intubation by novice paramedics: a randomized crossover simulation trial. Eur J Pediatr. 2015 Oct;174(10):1325-32. doi: 10.1007/s00431-015-2538-0. Epub 2015 Apr 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and TruView PCD Video laryngoscope 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 2 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 26 Jan 2015. 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 NCT02289872, 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 26 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.