IntubationNCT02280213
Comparison Four Intubation Devices
A study testing MIL, MAC and WIS in people with Intubation, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- MIL, MAC and WIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2014to Jan 2015
- 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
- paramedics
- no clinical experience in infant intubation
Who cannot join
- not meet the above criteria
- wrist or low back diseases
- pregnancy.
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: Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial
Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.
- Conditions
- Intubation
- Being tested
- MIL, MAC, WIS, PHIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILDevice
Also called Miller blade
Direct laryngoscopy 1
MACDevice
Also called Macintosh blade
Direct laryngoscopy 2
WISDevice
Also called Wis-Hipple blade
Direct laryngoscopy 3
PHILDevice
Also called Phillips blade
Direct laryngoscopy 4
| Study group | Role | What they receive |
|---|---|---|
| Intubation without chest compression | Experimental | Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions. Receives: Device: MIL; Device: MAC; Device: WIS; Device: PHIL |
| Intubation with chest compression | Experimental | Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year. Receives: Device: MIL; Device: MAC; Device: WIS; Device: PHIL |
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 (5)
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
Ease of Use
To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
Measured: 1 day
POGO score
The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.
Measured: 1 day
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Measured: 1 day
dental compression
pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3)
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 posted31 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- 145 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, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280213
- Sponsor's protocol ID
- ETI/2014/06
- Status last verified
- Jan 2015
- First submitted
- 28 Oct 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial
- ClinicalTrials.gov ID
- NCT02280213
- Acronym / sponsor ID
- ETI/2014/06
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Oct 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.
Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.
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: MIL, Device: MAC, Device: WIS, Device: PHILEndotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions. |
| Intubation with chest compression | Experimental | Device: MIL, Device: MAC, Device: WIS, Device: PHILEndotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year. |
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
- paramedics
- no clinical experience in infant intubation
Key exclusion criteria (3 listed)
- not meet the above criteria
- wrist or low back diseases
- pregnancy.
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 |
|---|---|---|
| MILAlso: Miller bladeDirect laryngoscopy 1 | Device | Intubation with chest compression, Intubation without chest compression |
| MACAlso: Macintosh bladeDirect laryngoscopy 2 | Device | Intubation with chest compression, Intubation without chest compression |
| WISAlso: Wis-Hipple bladeDirect laryngoscopy 3 | Device | Intubation with chest compression, Intubation without chest compression |
| PHILAlso: Phillips bladeDirect laryngoscopy 4 | Device | Intubation with chest compression, Intubation without chest compression |
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.
5 secondary outcomes
Success of intubation
Time frame: 1 day
Ease of Use
Time frame: 1 day
POGO score
Time frame: 1 day
Cormack-Lehane grading
Time frame: 1 day
dental compression
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 3 Feb 2015.
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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 principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIL, MAC and WIS in people with Intubation, 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 3 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 3 Feb 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?
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 3 Feb 2015.