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OpenTrials
Completed

NCT Number: NCT04365608

Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

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.

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Key information

Conditions

Intubation Complication COVID-19 Cardiac Arrest Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Arrest Heart Diseases Infections Influenza Influenza, Human Intubation; Difficult or Failed Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Safety Issues Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Medical Service, Poznan, Poland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct Laryngoscopy

Procedure

standard laryngoscope with Macintosh blade

Other names: MAC

Vie Scope laryngoscopy

Procedure

Vie Scope with dedicated bougie stylet

Other names: VCE

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Collaborators

  • Medical University of Bialystok
  • Poznan University of Medical Sciences
  • Wroclaw Medical University

Registry information

Official study title

Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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