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Pediatric Endotracheal Intubation (EMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291653
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Brief Summary:
We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS and MIL laryngoscopes in child resuscitation with and without CC.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Intubation, Endotracheal Device: McGrath Device: MIL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Novel McGrath MAC EMS Videolaryngoscope With Conventional Direct Laryngoscopy During Child Resuscitation: a Randomized Crossover Mannequin Study of Paramedic Students
Study Start Date : November 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Intubation without chest compressions
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Device: McGrath
video-laryngoscopy
Other Name: McGrath MAC EMS

Device: MIL
direct-laryngoscopy
Other Name: Miller Laryngoscope

Experimental: Intubation with uninterrupted chest compressions
Endotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).
Device: McGrath
video-laryngoscopy
Other Name: McGrath MAC EMS

Device: MIL
direct-laryngoscopy
Other Name: Miller Laryngoscope




Primary Outcome Measures :
  1. Success of intubation [ Time Frame: 1 day ]
    effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants


Secondary Outcome Measures :
  1. Intubation time [ Time Frame: 1 day ]
    time in seconds required for a successful intubation attempt

  2. Cormack-Lehane grading [ Time Frame: 1 day ]
    self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Give voluntary consent to participate in the study
  • paramedic student

Exclusion Criteria:

  • Not meet the above criteria
  • Wrist or Low back diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291653


Locations
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Poland
International Institute of Rescue Research and Education
Warsaw, Masovia, Poland, 03-122
Sponsors and Collaborators
International Institute of Rescue Research and Education
Investigators
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Principal Investigator: Lukasz Szarpak Institute of Cardiology
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Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02291653    
Other Study ID Numbers: ETI/2014/17
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases