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Endotracheal Intubation Devices (ETID)

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: NCT02277652
Recruitment Status : Unknown
Verified November 2014 by Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Study Description
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Brief Summary:
The purpose of this study was to compare the four different intubation devices in 6 different scenarios.

Condition or disease Intervention/treatment Phase
Intubation Device: The Miller Laryngoscope Device: The Bonfils intubation fibrescope Device: The GlideScope Ranger Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Four Different Endotracheal Intubation Devices Performed by Emergency Medical Professionals: a Manikin Study With 6 Airway Scenarios
Study Start Date : October 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Scenario 1: Uninterrupted chest compressions
Endotracheal intubation (ETI) during pediatric manikin with uninterrupted chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control, USA).
 Device: The Miller Laryngoscope
Direct laryngoscopy

Device: The Bonfils intubation fibrescope
Optical laryngoscopy

Device: The GlideScope Ranger
Videolaryngoscopy

Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT)
Blind intubation
Experimental: Scenario 2: Neutral position
ETI performed in neutral mannikin head position
 Device: The Miller Laryngoscope
Direct laryngoscopy

Device: The Bonfils intubation fibrescope
Optical laryngoscopy

Device: The GlideScope Ranger
Videolaryngoscopy

Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT)
Blind intubation
Experimental: Scenario 3: Sniffing position
ETI performed in sniffing mannikin head position
 Device: The Miller Laryngoscope
Direct laryngoscopy

Device: The Bonfils intubation fibrescope
Optical laryngoscopy

Device: The GlideScope Ranger
Videolaryngoscopy

Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT)
Blind intubation
Experimental: Scenario 4: Pharyngeal swelling
ETI performed during mannikin pharyngeal swelling scenario
 Device: The Miller Laryngoscope
Direct laryngoscopy

Device: The Bonfils intubation fibrescope
Optical laryngoscopy

Device: The GlideScope Ranger
Videolaryngoscopy

Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT)
Blind intubation
Experimental: Scenario 5: Swollen tongue
ETI performed during mannikin swollen tongue scenario
 Device: The Miller Laryngoscope
Direct laryngoscopy

Device: The Bonfils intubation fibrescope
Optical laryngoscopy

Device: The GlideScope Ranger
Videolaryngoscopy

Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT)
Blind intubation
Experimental: Scenario 6: Immobilized cervical spine
ETI performed during mannikin immobilized cervical spine scenario
 Device: The Miller Laryngoscope
Direct laryngoscopy

Device: The Bonfils intubation fibrescope
Optical laryngoscopy

Device: The GlideScope Ranger
Videolaryngoscopy

Device: The Supraglottic Airway Laryngopharyngeal Tube (SALT)
Blind intubation


Outcome Measures
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Primary Outcome Measures :
  1. Time to intubation [ Time Frame: 1 month ]
    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 month ]
    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. POGO score [ Time Frame: 1 month ]
    self-reported percentage of glottis opening (POGO) score

  3. VAS score [ Time Frame: 1 month ]
    participants were asked which method they would prefer in a real-life resuscitation.

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases
Contacts and Locations
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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): NCT02277652


Contacts
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Contact: Lukasz Szarpak (+48)500186225 lukasz.szarpak@gmail.com

Locations
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Poland
International Institute of Rescue Research and Education Recruiting
Warsaw, Masovia, Poland, 03-122
Contact: Lukasz Szarpak    (+48)500186225    lukasz.szarpak@gmail.com   
Sponsors and Collaborators
International Institute of Rescue Research and Education
Investigators
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Principal Investigator: Lukasz Szarpak Institute of Cardiology, Warsaw, Poland
Principal Investigator: Andrzej Kurowski Institute of Cardiology, Warsaw, Poland
More Information
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Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02277652    
Other Study ID Numbers: ETI/2014/03
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014