IntuBrite Versus Macintosh for Endotracheal Intubation in Out of Hospital Cardiac Arrest
Primary Purpose
Intubation Complication, Cardiopulmonary Arrest
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
IntuBrite intubation
Macintosh laryngoscope
Sponsored by
About this trial
This is an interventional other trial for Intubation Complication
Eligibility Criteria
Inclusion Criteria: patients in cardiac arrest , requiring cardiopulmonary resuscitation Exclusion Criteria: suspected difficult intubation
Sites / Locations
- Medical University of Lodz, Poland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intu-Brite
Macintosh
Arm Description
Use of new laryngoscope - IntuBrite for intubation
Use of standard laryngoscope with Macintosh blade for intubation
Outcomes
Primary Outcome Measures
Intubation time
Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2
Secondary Outcome Measures
Intubation success
Endotracheal intubation confirmed with EtCO2
intubation complications
intubation complications : esophageal intubation, injuries post intubation
Full Information
NCT ID
NCT05607836
First Posted
October 28, 2022
Last Updated
November 2, 2022
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT05607836
Brief Title
IntuBrite Versus Macintosh for Endotracheal Intubation in Out of Hospital Cardiac Arrest
Official Title
A Pilot, Prospective, Randomized Trial of IntuBrite Versus Macintosh Direct Laryngoscopy for Paramedic Endotracheal Intubation in Out of Hospital Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication, Cardiopulmonary Arrest
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intu-Brite
Arm Type
Experimental
Arm Description
Use of new laryngoscope - IntuBrite for intubation
Arm Title
Macintosh
Arm Type
Active Comparator
Arm Description
Use of standard laryngoscope with Macintosh blade for intubation
Intervention Type
Device
Intervention Name(s)
IntuBrite intubation
Intervention Description
Use of new laryngoscope IntuBrite for intubation in patients with cardiopulmonary arrest and during resuscitation
Intervention Type
Device
Intervention Name(s)
Macintosh laryngoscope
Intervention Description
Use of standard Macintosh blade laryngoscope for intubation in patients with cardiac arrest and requiring cardiopulmonary resuscitation
Primary Outcome Measure Information:
Title
Intubation time
Description
Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Intubation success
Description
Endotracheal intubation confirmed with EtCO2
Time Frame
1 minute
Title
intubation complications
Description
intubation complications : esophageal intubation, injuries post intubation
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in cardiac arrest , requiring cardiopulmonary resuscitation
Exclusion Criteria:
suspected difficult intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Gaszynski
Organizational Affiliation
Medical University of Lodz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Lodz, Poland
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IntuBrite Versus Macintosh for Endotracheal Intubation in Out of Hospital Cardiac Arrest
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