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Intubation During Resuscitation (IDR)

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ClinicalTrials.gov Identifier: NCT02277951
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Brief 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.


Condition or disease Intervention/treatment
Intubation Cardiopulmonary Resuscitation Device: The Bonfils Intubation Fibrescope Device: The Video Rigid Flexing Laryngoscope Device: The C-MAC® S Video Laryngoscope Device: The Macintosh Laryngoscope

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).

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Group/Cohort Intervention/treatment
Participants
The Bonfils Intubation Fibrescope the Video Rigid Flexing Laryngoscope the C-MAC® S Video Laryngoscope the Macintosh Laryngoscope
Device: The Bonfils Intubation Fibrescope
Effectiveness and time to successful intubation will be measured.

Device: The Video Rigid Flexing Laryngoscope
Effectiveness and time to successful intubation will be measured.

Device: The C-MAC® S Video Laryngoscope
Effectiveness and time to successful intubation will be measured.

Device: The Macintosh Laryngoscope
Effectiveness and time to successful intubation will be measured.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Personnel of emergency medical services and hospital emergency units
Criteria

Inclusion Criteria:

  • experienced emergency personnel: nurses, paramedics

Exclusion Criteria:

  • no experience in out-of-hospital emergency medicine
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Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02277951    
Other Study ID Numbers: InternationalIRRE
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014