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
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 28, 2022
CompletedFirst Posted
Study publicly available on registry
November 7, 2022
CompletedNovember 7, 2022
November 1, 2022
4 years
October 28, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intubation time
Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2
1 minute
Secondary Outcomes (2)
Intubation success
1 minute
intubation complications
5 minutes
Study Arms (2)
Intu-Brite
EXPERIMENTALUse of new laryngoscope - IntuBrite for intubation
Macintosh
ACTIVE COMPARATORUse of standard laryngoscope with Macintosh blade for intubation
Interventions
Use of new laryngoscope IntuBrite for intubation in patients with cardiopulmonary arrest and during resuscitation
Use of standard Macintosh blade laryngoscope for intubation in patients with cardiac arrest and requiring cardiopulmonary resuscitation
Eligibility Criteria
You may qualify if:
- patients in cardiac arrest , requiring cardiopulmonary resuscitation
You may not qualify if:
- suspected difficult intubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Lodz, Poland
Lodz, 90-153, Poland
Related Publications (1)
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.
PMID: 37349703DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tomasz Gaszynski
Medical University of Lodz, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2022
First Posted
November 7, 2022
Study Start
January 1, 2016
Primary Completion
January 1, 2020
Study Completion
June 1, 2022
Last Updated
November 7, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share