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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05607836
Enrollment
86
Registered
2022-11-07
Start date
2016-01-01
Completion date
2022-06-01
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Arrest, Intubation Complication

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.

Interventions

DEVICEIntuBrite intubation

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

DEVICEMacintosh laryngoscope

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

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients in cardiac arrest , requiring cardiopulmonary resuscitation

Exclusion criteria

* suspected difficult intubation

Design outcomes

Primary

MeasureTime frameDescription
Intubation time1 minuteEndotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2

Secondary

MeasureTime frameDescription
Intubation success1 minuteEndotracheal intubation confirmed with EtCO2
intubation complications5 minutesintubation complications : esophageal intubation, injuries post intubation

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026