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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intubation Complication, Cardiopulmonary Arrest

Intervention / Treatment
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* Device: IntuBrite intubation
* Device: Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients in cardiac arrest , requiring cardiopulmonary resuscitation Exclusion Criteria: suspected difficult intubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intu-Brite<br>Use of new laryngoscope - IntuBrite for intubation | Device: IntuBrite intubation<br>* Use of new laryngoscope IntuBrite for intubation in patients with cardiopulmonary arrest and during resuscitation<br>|
| Active Comparator: Macintosh<br>Use of standard laryngoscope with Macintosh blade for intubation | Device: Macintosh laryngoscope<br>* Use of standard Macintosh blade laryngoscope for intubation in patients with cardiac arrest and requiring cardiopulmonary resuscitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2 | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation success | Endotracheal intubation confirmed with EtCO2 | 1 minute | 
| intubation complications | intubation complications : esophageal intubation, injuries post intubation | 5 minutes |