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Intubation During Cardiopulmonary Resuscitation

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: NCT02804451
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Łukasz Szarpak, Medical University of Warsaw

Brief Summary:
The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation Device: Macintosh laryngoscope Device: TruView EVO2 laryngoscope Device: TruView EVO2 PCD laryngoscope Device: ETView SL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Intubation without chest compression
normal airway, without chest compression during intubation.
Device: Macintosh laryngoscope
intubation with standard macintosh larygoscope; gold standard
Other Name: MAC

Device: TruView EVO2 laryngoscope
A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
Other Name: EVO2

Device: TruView EVO2 PCD laryngoscope
A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
Other Name: PCD

Device: ETView SL
An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube
Other Name: ETView

Experimental: Intubation with uninterrupted chest compression
normal airway, with continuous chest compressions
Device: Macintosh laryngoscope
intubation with standard macintosh larygoscope; gold standard
Other Name: MAC

Device: TruView EVO2 laryngoscope
A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
Other Name: EVO2

Device: TruView EVO2 PCD laryngoscope
A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
Other Name: PCD

Device: ETView SL
An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube
Other Name: ETView




Primary Outcome Measures :
  1. time to the first ventilation attempt [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. time to visualize the larynx [ Time Frame: 1 day ]
  2. time to introduce the endotracheal tube through the vocal cords [ Time Frame: 1 day ]
  3. success rate [ Time Frame: 1 day ]
    first intubation attempt success rate

  4. degree of larynx visibility [ Time Frame: 1 day ]
    analysed based on a Cormack-Lehane scale

  5. ease of intubation technique [ Time Frame: 1 day ]
    10-point visual analogue scale (VAS) was used, where 1 indicated an extremely simple procedure, while 10 - an extremely difficult one



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

Inclusion Criteria:

  • had not received any training in endotracheal intubation with videolaryngoscopy before the study,
  • had nursing specialization in anaesthesiology or emergency medicine,
  • presented with no wrist or low back diseases or pregnancy.

Exclusion Criteria:

  • not meet the above criteria.

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): NCT02804451


Locations
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Poland
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, Poland, 02-005
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Lukasz Szarpak, PhD Medical University of Warsaw
Publications:
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Responsible Party: Łukasz Szarpak, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02804451    
Other Study ID Numbers: 03/02/2016
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016