Medical University of Lodz, Poland
Lodz, 90-153, Poland
NCT Number: NCT05607836
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lodz, 90-153, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 minute
Endotracheal intubation from grabbing device to placement of tube in the trachea confirmed by EtCO2
Time frame: 1 minute
Endotracheal intubation confirmed with EtCO2
Time frame: 5 minutes
intubation complications : esophageal intubation, injuries post intubation
Medical University of Lodz
Other
A Pilot, Prospective, Randomized Trial of IntuBrite Versus Macintosh Direct Laryngoscopy for Paramedic Endotracheal Intubation in Out of Hospital Cardiac Arrest
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04365608
COVID-19, Cardiac Arrest
Poznan, Poland
View Trial DetailsNCT06113939
Airway Clearance Impairment, Brain Diseases
Madrid, Spain
View Trial DetailsNCT06750939
Anaesthetic Complication Cardiac, Cardiovascular Collapse
Köseköy, Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT06327399
Dexmedetomidine, Intubation Complication
Giza, Giza Governorate, Egypt
View Trial Details