NCT07524881

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 15, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

April 6, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

OHCAendotracheal intubationcardiopulmonary resuscitationsurvival

Outcome Measures

Primary Outcomes (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.

    At 28 days after ACLS initiation following OHCA.

Secondary Outcomes (3)

  • Neurological Status at 28 Days

    At 28 days after ACLS initiation following OHCA

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

    Assessed within the first 20 minutes after emergency department admission.

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

    At 28 days after ACLS initiation following OHCA

Study Arms (5)

Survivors

Survivors were defined as the patient being alive at 28 days following the cardiac arrest event.

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Arterial Blood Gas Parameters

Non-survivors

Non-survivors had passed away within 28 days following the cardiac arrest event.

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Arterial Blood Gas Parameters

Successful ETI

Adult 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).

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Arterial Blood Gas ParametersOther: 28-day survivalOther: Neurological outcome

Failed ETI attempt

Adult patients with OHCA who underwent a failed prehospital ETI attempt by EMS personnel before arrival at the ED.

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Arterial Blood Gas ParametersOther: 28-day survivalOther: Neurological outcome

No ETI attempt

Adult patients with OHCA in whom no prehospital ETI attempt was performed by EMS personnel before arrival at the ED.

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Arterial Blood Gas ParametersOther: 28-day survivalOther: Neurological outcome

Interventions

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

Failed ETI attemptNo ETI attemptSuccessful ETI

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.

Failed ETI attemptNo ETI attemptSuccessful ETI

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

Failed ETI attemptNo ETI attemptNon-survivorsSuccessful ETISurvivors

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.

Failed ETI attemptNo ETI attemptNon-survivorsSuccessful ETISurvivors

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.

Failed ETI attemptNo ETI attemptNon-survivorsSuccessful ETISurvivors

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

Failed ETI attemptNo ETI attemptNon-survivorsSuccessful ETISurvivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Sultangazi, Istanbul, 34265, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Interventions

DemographyComorbidity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Adem Az

    Sultangazi Haseki Eğitim ve Araştırma Hastanesi, Başhekimlik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 15, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Stored in non-publicly avaliableAvaliable on request

Locations