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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

Tracking Information
First Submitted Date October 16, 2014
First Posted Date October 29, 2014
Last Update Posted Date October 29, 2014
Study Start Date May 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2014)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intubation During Resuscitation
Official Title Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Personnel of emergency medical services and hospital emergency units
Condition
  • Intubation
  • Cardiopulmonary Resuscitation
Intervention
  • 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.
Study Groups/Cohorts Participants
The Bonfils Intubation Fibrescope the Video Rigid Flexing Laryngoscope the C-MAC® S Video Laryngoscope the Macintosh Laryngoscope
Interventions:
  • Device: The Bonfils Intubation Fibrescope
  • Device: The Video Rigid Flexing Laryngoscope
  • Device: The C-MAC® S Video Laryngoscope
  • Device: The Macintosh Laryngoscope
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 27, 2014)
141
Original Actual Enrollment Same as current
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • experienced emergency personnel: nurses, paramedics

Exclusion Criteria:

  • no experience in out-of-hospital emergency medicine
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02277951
Other Study ID Numbers InternationalIRRE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
Study Sponsor International Institute of Rescue Research and Education
Collaborators Not Provided
Investigators Not Provided
PRS Account International Institute of Rescue Research and Education
Verification Date October 2014