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Out of Hospital Cardiac ArrestETIOHCANCT07524881

Prehospital ETI in OHCA

An observational study of Out of Hospital Cardiac Arrest and Cardiac Arrest (CA), run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Demographics, Comorbidities and Prehospital Variables
How many people
297 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2025to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study included 361 adult patients (aged ≥18 years) who were brought to our hospital's ED due to OHCA and who had initiated attempted resuscitation by EMS were initially screened for inclusion between July 1, 2025, and December 31, 2025.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Haseki Training and Research Hospital

    Sultangazi, Istanbul, 34265

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Demographics, Comorbidities, Prehospital Variables, Arterial Blood Gas Parameters, 28-day survival
Keywords
OHCA, endotracheal intubation, cardiopulmonary resuscitation, survival
Medical subject headings
Out-of-Hospital Cardiac Arrest, Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DemographicsOther

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

  • ComorbiditiesOther

    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 VariablesOther

    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 ParametersDiagnostic test

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

  • 28-day survivalOther

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

  • Neurological outcomeOther

    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.

Study groups in NCT07524881
Study groupRoleWhat they receive
SurvivorsSurvivors were defined as the patient being alive at 28 days following the cardiac arrest event.
Receives: Other: Demographics; Other: Comorbidities; Other: Prehospital Variables; Diagnostic Test: Arterial Blood Gas Parameters
Non-survivorsNon-survivors had passed away within 28 days following the cardiac arrest event.
Receives: Other: Demographics; Other: Comorbidities; Other: Prehospital Variables; Diagnostic Test: Arterial Blood Gas Parameters
Successful ETIAdult patients with out-of-hospital cardiac arrest (OHCA) who underwent a successful prehospital endotracheal intubation (ETI) attempt by emergency medical services (EMS) personnel before arrival at the emergency department (ED).
Receives: Other: Demographics; Other: Comorbidities; Other: Prehospital Variables; Diagnostic Test: Arterial Blood Gas Parameters; Other: 28-day survival; Other: Neurological outcome
Failed ETI attemptAdult patients with OHCA who underwent a failed prehospital ETI attempt by EMS personnel before arrival at the ED.
Receives: Other: Demographics; Other: Comorbidities; Other: Prehospital Variables; Diagnostic Test: Arterial Blood Gas Parameters; Other: 28-day survival; Other: Neurological outcome
No ETI attemptAdult patients with OHCA in whom no prehospital ETI attempt was performed by EMS personnel before arrival at the ED.
Receives: Other: Demographics; Other: Comorbidities; Other: Prehospital Variables; Diagnostic Test: Arterial Blood Gas Parameters; Other: 28-day survival; Other: Neurological outcome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28 day-survival rate

    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.

    Measured: At 28 days after ACLS initiation following OHCA.

Secondary outcomes (3)
  1. Neurological Status at 28 Days

    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.

    Measured: At 28 days after ACLS initiation following OHCA

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

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

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

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

    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.

    Measured: At 28 days after ACLS initiation following OHCA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start1 Jul 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524881
Sponsor's protocol ID
96-2025
Acronym
ETIOHCA
Status last verified
Feb 2026
First submitted
6 Apr 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Stored in non-publicly avaliableAvaliable on request

Publications

  • Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA. Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):779-791. doi: 10.1001/jama.2018.11597.

    PubMed 30167701
  • Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.

    PubMed 30167699
  • Jabre P, Penaloza A, Pinero D, Duchateau FX, Borron SW, Javaudin F, Richard O, de Longueville D, Bouilleau G, Devaud ML, Heidet M, Lejeune C, Fauroux S, Greingor JL, Manara A, Hubert JC, Guihard B, Vermylen O, Lievens P, Auffret Y, Maisondieu C, Huet S, Claessens B, Lapostolle F, Javaud N, Reuter PG, Baker E, Vicaut E, Adnet F. Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial. JAMA. 2018 Feb 27;319(8):779-787. doi: 10.1001/jama.2018.0156.

    PubMed 29486039
  • White L, Melhuish T, Holyoak R, Ryan T, Kempton H, Vlok R. Advanced airway management in out of hospital cardiac arrest: A systematic review and meta-analysis. Am J Emerg Med. 2018 Dec;36(12):2298-2306. doi: 10.1016/j.ajem.2018.09.045. Epub 2018 Sep 26.

    PubMed 30293843
  • Pollack RA, Brown SP, Rea T, Aufderheide T, Barbic D, Buick JE, Christenson J, Idris AH, Jasti J, Kampp M, Kudenchuk P, May S, Muhr M, Nichol G, Ornato JP, Sopko G, Vaillancourt C, Morrison L, Weisfeldt M; ROC Investigators. Impact of Bystander Automated External Defibrillator Use on Survival and Functional Outcomes in Shockable Observed Public Cardiac Arrests. Circulation. 2018 May 15;137(20):2104-2113. doi: 10.1161/CIRCULATIONAHA.117.030700. Epub 2018 Feb 26.

    PubMed 29483086
  • Hasselqvist-Ax I, Riva G, Herlitz J, Rosenqvist M, Hollenberg J, Nordberg P, Ringh M, Jonsson M, Axelsson C, Lindqvist J, Karlsson T, Svensson L. Early cardiopulmonary resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2307-15. doi: 10.1056/NEJMoa1405796.

    PubMed 26061835
  • Akdemir T, Az A, Dogan Y, Sogut O. Clinical and laboratory predictors of 28-day survival and neurologic outcome in out-of-hospital cardiac arrest: A prospective cohort study. Ir J Med Sci. 2025 Dec;194(6):2485-2495. doi: 10.1007/s11845-025-04121-0. Epub 2025 Oct 20.

    PubMed 41114924

Questions about this trial

What is this clinical trial studying?

An observational study of Out of Hospital Cardiac Arrest and Cardiac Arrest (CA), run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28 day-survival rate (time frame: At 28 days after ACLS initiation following OHCA.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07524881, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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