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Comparison Four Intubation Devices

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ClinicalTrials.gov Identifier: NCT02280213
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Brief Summary:
Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.

Condition or disease Intervention/treatment Phase
Intubation Device: MIL Device: MAC Device: WIS Device: PHIL Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Intubation without chest compression
Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.
Device: MIL
Direct laryngoscopy 1
Other Name: Miller blade

Device: MAC
Direct laryngoscopy 2
Other Name: Macintosh blade

Device: WIS
Direct laryngoscopy 3
Other Name: Wis-Hipple blade

Device: PHIL
Direct laryngoscopy 4
Other Name: Phillips blade

Experimental: Intubation with chest compression
Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.
Device: MIL
Direct laryngoscopy 1
Other Name: Miller blade

Device: MAC
Direct laryngoscopy 2
Other Name: Macintosh blade

Device: WIS
Direct laryngoscopy 3
Other Name: Wis-Hipple blade

Device: PHIL
Direct laryngoscopy 4
Other Name: Phillips blade




Primary Outcome Measures :
  1. Time to intubation [ Time Frame: 1 day ]
    time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.


Secondary Outcome Measures :
  1. Success of intubation [ Time Frame: 1 day ]
    effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.

  2. Ease of Use [ Time Frame: 1 day ]
    To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).

  3. POGO score [ Time Frame: 1 day ]
    The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.

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

  5. dental compression [ Time Frame: 1 day ]
    pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3)



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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
  • paramedics
  • no clinical experience in infant intubation

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases
  • pregnancy.

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): NCT02280213


Locations
Poland
International Institute of Rescue Research and Education
Warsaw, Masovia, Poland, 03-122
Sponsors and Collaborators
International Institute of Rescue Research and Education
Investigators
Principal Investigator: Lukasz Szarpak Institute of Cardiology, Warsaw, Poland

Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02280213     History of Changes
Other Study ID Numbers: ETI/2014/06
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015