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Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365608
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Poznan University of Medical Sciences
Wroclaw Medical University
Medical University of Bialystok
Information provided by (Responsible Party):
Łukasz Szarpak, Lazarski University

Brief Summary:
The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Condition or disease Intervention/treatment Phase
Intubation Complication Intubation; Difficult or Failed Cardiac Arrest Influenza Safety Issues Procedure: Direct laryngoscopy Procedure: Vie Scope laryngoscopy Not Applicable

Detailed Description:
Intubation will be carried out in full personal protective equipment conditions of the operator

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Active Comparator: Direct laryngoscopy
Intubation will be done using direct laryngoscopy. The standard intubation procedure is to use a styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the guidelines on difficult airway management.
Procedure: Direct laryngoscopy
standard laryngoscope with Macintosh blade
Other Name: MAC

Active Comparator: Vie Scope laryngoscopy
Intubation will be done using Vie Scope laryngoscopy
Procedure: Vie Scope laryngoscopy
Vie Scope with dedicated bougie stylet
Other Name: VCE




Primary Outcome Measures :
  1. Intubation success rate during at the first laryngoscopy [ Time Frame: 10 min ]
    Definition of failed intubation: Time to intubation is longer than 120 seconds or wrong placement of endotracheal tube (For example : Esophageal intubation etc.)


Secondary Outcome Measures :
  1. Intubation difficulty Scale score [ Time Frame: 10 min ]
    Intubation difficulty assessed by Intubation difficulty Scale score

  2. Complications related to tracheal intubation [ Time Frame: 10 min ]
    Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation

  3. Time to completion of tracheal intubation (TI) procedure [ Time Frame: 10 min ]
    Time to completion of tracheal intubation (TI) procedure measured from the instant that the laryngoscope blade touches the patient to the moment that the tracheal tube cuff is inflated

  4. Duration of the interruption of chest compression during ETI procedure [ Time Frame: 10 min ]
    Duration of the interruption of chest compression during ETI procedure

  5. Laryngeal View during intubation [ Time Frame: 10 min ]
    We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.

  6. POGO score [ Time Frame: 10 min ]
    self-reported percentage of glottis opening (POGO) score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients requiring out-of-hospital intubation

Exclusion Criteria:

  • Patient under 18 years old
  • Patients with criteria predictive of impossible intubation under direct laryngoscopy

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): NCT04365608


Contacts
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Contact: Lukasz Szarpak, PhD 500186225 lukasz.szarpak@gmail.com

Locations
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Poland
Emergency Medical Service Recruiting
Poznan, Poland
Contact: Marek Dabrowski, PhD    504136807    maro.dabrowski@gmail.com   
Emergency Medical Service Recruiting
Warsaw, Poland
Contact: Lukasz Szarpak, PhD    500186225    lukasz.szarpak@gmail.com   
Sponsors and Collaborators
Lazarski University
Poznan University of Medical Sciences
Wroclaw Medical University
Medical University of Bialystok
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Responsible Party: Łukasz Szarpak, Assoc Prof PhD, Lazarski University
ClinicalTrials.gov Identifier: NCT04365608    
Other Study ID Numbers: INT_EMS_PPE_1
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: after manuscript publishing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Łukasz Szarpak, Lazarski University:
endotracheal intubation
cardiac arrest
personal protective equipment
laryngoscope
Vie Scope
COVID-19
SARS-CoV-2
emergency medicine
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases