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

Not Applicable

Completed

• Conditions: Cardiopulmonary Arrest; Intubation Complication
• Interventions: Device: Macintosh laryngoscope; Device: IntuBrite intubation

• Registration Number: NCT05607836
• Lead Sponsor: Medical University of Lodz

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2022-06-01
• Study First Submitted: 2022-10-28
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-07
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• patients in cardiac arrest , requiring cardiopulmonary resuscitation

Exclusion Criteria

• suspected difficult intubation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh	Macintosh laryngoscope	Use of standard laryngoscope with Macintosh blade for intubation
Intu-Brite	IntuBrite intubation	Use of new laryngoscope - IntuBrite for intubation

Primary Outcome Measures

Name	Time	Method
Intubation time	1 minute	Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2

Secondary Outcome Measures

Name	Time	Method
Intubation success	1 minute	Endotracheal intubation confirmed with EtCO2
intubation complications	5 minutes	intubation complications : esophageal intubation, injuries post intubation

Trial Locations

Locations (1)

Medical University of Lodz, Poland; 🇵🇱 Łódź, Poland