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

NCT ID: NCT05607836

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2022-06-01

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.

Conditions

Intubation Complication; Cardiopulmonary Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intu-Brite

Use of new laryngoscope - IntuBrite for intubation

Group Type: EXPERIMENTAL

IntuBrite intubation

Intervention Type: DEVICE

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

Macintosh

Use of standard laryngoscope with Macintosh blade for intubation

Group Type: ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type: DEVICE

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

Interventions

IntuBrite intubation

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

Intervention Type: DEVICE

Macintosh laryngoscope

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients in cardiac arrest , requiring cardiopulmonary resuscitation

Exclusion Criteria

• suspected difficult intubation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Gaszynski

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz, Poland

Locations

Medical University of Lodz, Poland

Lodz, , Poland

Countries

Poland

References

Kluj P, Fedorczak M, Gaszynski T, Ratajczyk P. A pilot, prospective trial of IntuBrite(R) versus Macintosh direct laryngoscopy for paramedic endotracheal intubation in out of hospital cardiac arrest. BMC Emerg Med. 2023 Jun 23;23(1):70. doi: 10.1186/s12873-023-00845-3.

Reference Type: DERIVED

PMID: 37349703 (View on PubMed)

Other Identifiers

RNN/06/20/KE

Identifier Type: -

Identifier Source: org_study_id