IntubationIDRNCT02277951
Intubation During Resuscitation
An observational study of Intubation and Cardiopulmonary Resuscitation, run by International Institute of Rescue Research and Education.
Trial summary
The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model. The investigators hypothesized that fiberoscope laryngoscopes may improve success rates. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation, Cardiopulmonary Resuscitation
- What is being tested?
- The Bonfils Intubation Fibrescope, The Video Rigid Flexing Laryngoscope and The C-MAC® S Video Laryngoscope
- Type of treatment
- Medical device
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jul 2014
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Personnel of emergency medical services and hospital emergency units
Who may be able to join
- experienced emergency personnel: nurses, paramedics
Who cannot join
- no experience in out-of-hospital emergency medicine
About this study
Official title: Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions
The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model.
The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.
Read the detailed description
Devices using in study:
The Bonfils Intubation Fibrescope (BONFILS)(KARL STORZ Endovision, Inc., Charlton, MA, USA), The Video Rigid Flexing Laryngoscope (RIFL)( AI Medical Devices, Inc., Williamston, MI, USA), The C-MAC® S Video Laryngoscope Blade Mac#3(C-MAC®S) (KARL STORZ Endovision, Inc., Charlton, MA, USA) The Macintosh Laryngoscope Blade no. 3 (MAC) (LifeLine Medical, Inc., Brooksville, FL, USA).
- Conditions
- Intubation, Cardiopulmonary Resuscitation
- Being tested
- The Bonfils Intubation Fibrescope, The Video Rigid Flexing Laryngoscope, The C-MAC® S Video Laryngoscope, The Macintosh Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Bonfils Intubation FibrescopeDevice
Effectiveness and time to successful intubation will be measured.
The Video Rigid Flexing LaryngoscopeDevice
Effectiveness and time to successful intubation will be measured.
The C-MAC® S Video LaryngoscopeDevice
Effectiveness and time to successful intubation will be measured.
The Macintosh LaryngoscopeDevice
Effectiveness and time to successful intubation will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Participants | The Bonfils Intubation Fibrescope the Video Rigid Flexing Laryngoscope the C-MAC® S Video Laryngoscope the Macintosh Laryngoscope Receives: Device: The Bonfils Intubation Fibrescope; Device: The Video Rigid Flexing Laryngoscope; Device: The C-MAC® S Video Laryngoscope; Device: The Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful intubation
The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.
Measured: Subjects complete study in 1 day
Success rate of ETI
The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.
Measured: Subjects complete study in 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 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
- NCT02277951
- Sponsor's protocol ID
- InternationalIRRE
- Acronym
- IDR
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions
- ClinicalTrials.gov ID
- NCT02277951
- Acronym / sponsor ID
- IDR / InternationalIRRE
- Conditions
- Intubation, Cardiopulmonary Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 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.
The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model.
The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.
Detailed description
Devices using in study:
The Bonfils Intubation Fibrescope (BONFILS)(KARL STORZ Endovision, Inc., Charlton, MA, USA), The Video Rigid Flexing Laryngoscope (RIFL)( AI Medical Devices, Inc., Williamston, MI, USA), The C-MAC® S Video Laryngoscope Blade Mac#3(C-MAC®S) (KARL STORZ Endovision, Inc., Charlton, MA, USA) The Macintosh Laryngoscope Blade no. 3 (MAC) (LifeLine Medical, Inc., Brooksville, FL, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: The Bonfils Intubation Fibrescope, Device: The Video Rigid Flexing Laryngoscope, Device: The C-MAC® S Video Laryngoscope, Device: The Macintosh LaryngoscopeThe Bonfils Intubation Fibrescope the Video Rigid Flexing Laryngoscope the C-MAC® S Video Laryngoscope the Macintosh Laryngoscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Personnel of emergency medical services and hospital emergency units
Key inclusion criteria (1 listed)
- experienced emergency personnel: nurses, paramedics
Key exclusion criteria (1 listed)
- no experience in out-of-hospital emergency medicine
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 |
|---|---|---|
| The Bonfils Intubation FibrescopeEffectiveness and time to successful intubation will be measured. | Device | Participants |
| The Video Rigid Flexing LaryngoscopeEffectiveness and time to successful intubation will be measured. | Device | Participants |
| The C-MAC® S Video LaryngoscopeEffectiveness and time to successful intubation will be measured. | Device | Participants |
| The Macintosh LaryngoscopeEffectiveness and time to successful intubation will be measured. | Device | Participants |
Primary outcome
Time to successful intubation
Time frame: Subjects complete study in 1 day
The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.
Success rate of ETI
Time frame: Subjects complete study in 1 day
The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.
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 29 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation and Cardiopulmonary Resuscitation, run by International Institute of Rescue Research and Education.
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 1 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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 successful intubation (time frame: Subjects complete study in 1 day). The study lists 2 primary outcomes in all. 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 29 Oct 2014.