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Completed

NCT Number: NCT07524881

Prehospital ETI in OHCA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Research Hospital

Sultangazi, Istanbul, 34265, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Out-of-hospital cardiac arrest (OHCA)
  • Transport to the emergency department by emergency medical services (EMS)
  • Initiated resuscitation/advanced cardiovascular life support (ACLS) by EMS
  • Enrollment period between July 1, 2025, and December 31, 2025

Exclusion criteria

  • Age <18 years
  • In-hospital cardiac arrest
  • Cardiac arrest due to major trauma, drowning, drug overdose, or known terminal illness
  • Tracheostomy present
  • Missing data on primary outcomes or admission laboratory parameters

Treatment and study plan

Demographics

Other

The demographic profile of each patient was documented, including age and sex, to examine potential associations with survival and neurological outcomes.

Comorbidities

Other

Data 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.

Prehospital Variables

Other

Several 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.

Arterial Blood Gas Parameters

Diagnostic Test

Arterial blood gas parameters, including pH, partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2), were also documented.

28-day survival

Other

Survival status 28 days after advanced cardiac life support (ACLS) initiated following OHCA.

Neurological outcome

Other

Neurological 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.

Primary outcomes

  1. 28 day-survival rate

    Time frame: At 28 days after ACLS initiation following OHCA.

    Survival status at day 28 after advanced cardiovascular life support (ACLS) initiated following out-of-hospital cardiac arrest (OHCA). Participants will be classified as survivors if alive on day 28 and as non-survivors if death occurs within 28 days.

Secondary outcomes

  1. Neurological Status at 28 Days

    Time frame: At 28 days after ACLS initiation following OHCA

    Neurological status assessed 28 days after ACLS initiation following OHCA using the Cerebral Performance Category (CPC) scale. Favorable neurological outcome will be defined as CPC 1-2, and unfavorable neurological outcome as CPC 3-5.

  2. Achievement of Return of Spontaneous Circulation (ROSC) During Resuscitation Following Out-of-Hospital Cardiac Arrest (OHCA).

    Time frame: Assessed within the first 20 minutes after emergency department admission.

    ROSC was defined as the return of sustained spontaneous perfusing rhythm lasting at least 20 minutes without the need for external chest compressions.

  3. Comparison of 28-Day Survival Rates Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not

    Time frame: At 28 days after ACLS initiation following OHCA

    The investigators evaluate the impact of prehospital endotracheal intubation (ETI) on 28-day survival status. Survival was defined as being alive 28 days after the cardiac arrest event. Participants will be categorized into two groups based on whether or not they received ETI in the prehospital setting.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: ETIOHCA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 15, 2026

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.

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