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OpenTrials
Completed

NCT Number: NCT05607836

IntuBrite Versus Macintosh for Endotracheal Intubation in Out of Hospital Cardiac Arrest

a randomized, parallel, non-blinded trial in a single Emergency Mdeical Service in Poland within a group of 34 ground ambulances crews, comparing time and first pass success (FPS) for endotracheal intubation (ETI) in DL using the IntuBrite® (INT) and Macintosh laryngoscope (MCL) during cardiopulmonary resuscitation (CPR). intubations will be performed using INT and MCL based on an intention-to-treat analysis. The FPS time of the ETI attempt will be analysed. First attempt success will be counted.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Lodz, Poland

Lodz, 90-153, Poland

About this study

Investigators designed a prospective observational study to compare INT (IntuBrite®, LLC; Vista, CA, USA) and MCL for ETI performed by paramedics in OHCA without an emergency physician on the scene. The main goal was to determine whether INT is superior to using an MCL laryngoscope during a tracheal intubation attempt in nontraumatic OHCA, in terms of time and effectiveness.

The time of intubation was measured using an electronic stopwatch. Time measurement began when the paramedic held the selected laryngoscope and declared their readiness to perform the procedure.

The effectiveness of the first ETI attempt for instrumental airway management for nontraumatic adult OHCA and end-tidal carbon dioxide monitoring was used to confirm correct device placement in all patients.

The degree difficulty of intubation attempts for all of the patients included in the study. A long-term survival and a cost-effectiveness analysis were not included within this trial.

The investigators will collect case report forms (CRFs) from patients after OHCA within a 40-month period.

The average professional experience of the paramedics in instrumental airway management will be noted (DL and LMA). The primary outcome is the FPS time of the ETI attempt performed by the paramedics.

The success rate on the first intubation attempt will be counted.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients in cardiac arrest , requiring cardiopulmonary resuscitation

Exclusion criteria

  • suspected difficult intubation

Treatment and study plan

IntuBrite intubation

Device

Use of new laryngoscope IntuBrite for intubation in patients with cardiopulmonary arrest and during resuscitation

Macintosh laryngoscope

Device

Use of standard Macintosh blade laryngoscope for intubation in patients with cardiac arrest and requiring cardiopulmonary resuscitation

Primary outcomes

  1. Intubation time

    Time frame: 1 minute

    Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2

Secondary outcomes

  1. Intubation success

    Time frame: 1 minute

    Endotracheal intubation confirmed with EtCO2

  2. intubation complications

    Time frame: 5 minutes

    intubation complications : esophageal intubation, injuries post intubation

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

A Pilot, Prospective, Randomized Trial of IntuBrite Versus Macintosh Direct Laryngoscopy for Paramedic Endotracheal Intubation in Out of Hospital Cardiac Arrest

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Nov 7, 2022
Registry last updated
Nov 7, 2022

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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