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Trials / Completed

CompletedNCT07524881

Prehospital ETI in OHCA

Association of Prehospital Endotracheal Intubation With 28-Day Survival and Neurological Outcomes in Out-of-Hospital Cardiac Arrest

Status
Completed
Phase
Study type
Observational
Enrollment
297 (actual)
Sponsor
Haseki Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This prospective observational study evaluated the association of prehospital endotracheal intubation (ETI) status with return of spontaneous circulation (ROSC), 28-day survival, and favorable neurological outcome in adult patients with out-of-hospital cardiac arrest (OHCA) transported to the emergency department (ED) by emergency medical services (EMS). In addition, the study investigated the causes of failed ETI attempts and examined other clinical factors associated with 28-day survival, including bystander cardiopulmonary resuscitation (CPR), initial cardiac rhythm, blood gas parameters, and prehospital airway management strategy.

Detailed description

This prospective observational cohort study was conducted in the ED of Haseki Training and Research Hospital between July 1, 2025, and December 31, 2025. Patients presenting to the ED with cardiac arrest during the study period were screened for eligibility. All patients received advanced cardiac life support (ACLS) in accordance with the 2025 European Resuscitation Council (ERC) guidelines. Data collected for each patient encompassed demographic characteristics (age, sex, and body mass index \[BMI\]) and comorbid conditions, including hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease, and malignancy. Prehospital variables included witnessed arrest, bystander CPR, bystander automated external defibrillator (AED) use, no-flow duration, time from collapse to initiation of advanced life support (ALS), time from collapse to hospital arrival, hyperventilation, and initial cardiac rhythm (asystole/pulseless electrical activity \[PEA\] or ventricular fibrillation/pulseless ventricular tachycardia \[VF/pVT\]). Prehospital airway data were recorded in two ways: the airway device present on ED arrival (endotracheal tube in place, bag-valve-mask ventilation, or supraglottic airway) and prehospital ETI attempt status (successful ETI, failed ETI attempt, or no ETI attempt). ETI success and the reasons for failed ETI attempts were also recorded, as was the occurrence of prehospital ROSC. Upon arrival at the ED, body temperature, Glasgow Coma Scale (GCS) score (when assessable), and vasopressor use within the first hour were recorded. Arterial blood gas parameters, including pH, partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2), were also documented. Clinical outcomes included ROSC, 28-day survival status, and neurological outcome. Patients were classified as survivors or non-survivors according to 28-day survival status. Demographic characteristics, comorbidities, prehospital time intervals, initial rhythm, blood gas parameters, and airway management variables were compared across these groups to identify factors associated with 28-day survival. For airway-specific analyses, patients were further categorized into three groups according to ETI status: successful ETI, failed ETI attempt, and no ETI attempt. Comparisons among these groups were performed to assess differences in demographic and clinical characteristics, prehospital resuscitation variables, ROSC, 28-day survival, and favorable neurological outcome according to ETI status.

Conditions

Interventions

TypeNameDescription
OTHERDemographicsThe demographic profile of each patient was documented, including age and sex, to examine potential associations with survival and neurological outcomes.
OTHERComorbiditiesData on pre-existing chronic conditions were recorded, such as hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease, and malignancy, in order to assess their potential impact on prognosis following OHCA.
OTHERPrehospital VariablesSeveral prehospital factors were evaluated, including whether the cardiac arrest was witnessed, whether bystander cardiopulmonary resuscitation (CPR) was performed, the time from collapse to the initiation of CPR, and the time from collapse to EMS arrival. Additionally, the durations of no-flow (i.e., time without any CPR) and low-flow (i.e., time with CPR but without ROSC) were noted. The initial cardiac rhythm was categorized as ventricular fibrillation or pulseless ventricular tachycardia (VF/pVT), asystole, or pulseless electrical activity (PEA). Airway management methods used in the field were documented and classified as bag-valve-mask (BVM), supraglottic airway devices (SGAs), or endotracheal intubation (ETI). Other recorded interventions included prehospital defibrillation, administration of epinephrine (including total dosage), and use of mechanical chest compression devices. Whether ROSC was achieved prior to arrival at the emergency department was also noted.
DIAGNOSTIC_TESTArterial Blood Gas ParametersArterial blood gas parameters, including pH, partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2), were also documented.
OTHER28-day survivalSurvival status 28 days after advanced cardiac life support (ACLS) initiated following OHCA.
OTHERNeurological outcomeNeurological status assessed at day 28 using the Cerebral Performance Category (CPC) scale. Favorable neurological outcome was defined as CPC 1-2, and unfavorable neurological outcome was defined as CPC 3-5.

Timeline

Start date
2025-07-01
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2026-04-13
Last updated
2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07524881. Inclusion in this directory is not an endorsement.