Out of Hospital Cardiac ArrestOHCAstdNCT07023159
Predicting 28-Day Survival in OHCA Patients
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).
Trial summary
This prospective study aimed to identify clinical and laboratory predictors of return of spontaneous circulation (ROSC), 28-day survival, and favorable neurological outcomes in adult patients experiencing out-of-hospital cardiac arrest (OHCA) and brought to the emergency department (ED) by emergency medical services… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest, Cardiac Arrest (CA)
- What is being tested?
- Demographics, Comorbidities and Prehospital Variables
- How many people
- 327 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jun 2024
- 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 420 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 May 2023 and May 2024.
Who may be able to join
- This study included 420 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 May 2023 and May 2024.
Who cannot join
- Patients aged < 18 years
- Patients with in-hospital cardiac arrest
- Patients who have suffered cardiac arrest due to major trauma, drowning, drug overdose, or known terminal illness
- Patients with active hematologic malignancy
- Patients with incomplete data regarding primary outcomes or admission laboratory tests
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
About this study
Official title: Predicting Clinical Factors and Laboratory Parameters Associated With Short-Term Survival in Out-of-Hospital Cardiac Arrest
This prospective study aimed to identify clinical and laboratory predictors of return of spontaneous circulation (ROSC), 28-day survival, and favorable neurological outcomes in adult patients experiencing out-of-hospital cardiac arrest (OHCA) and brought to the emergency department (ED) by emergency medical services (EMS). Specifically, the prognostic value of hematologic, biochemical, and blood gas parameters on admission was assessed for ROSC, 28-day survival, and favorable neurological recovery. Additionally, the study investigated the influence of key patient-centered and prehospital variables, including demographic features, initial cardiac rhythm, and the timeliness and type of cardiopulmonary resuscitation (CPR), defibrillation, and airway interventions, on overall survival and neurological status.
Read the detailed description
This prospective, observational, and cross-sectional study was conducted in the ED of a tertiary urban hospital between May 2023 and May 2024. Adult patients (aged ≥18 years) who experienced OHCA and received attempted resuscitation by EMS personnel were screened for eligibility. All patients received advanced cardiac life support (ACLS) in accordance with the 2021 European Resuscitation Council (ERC) and 2020 American Heart Association (AHA) guidelines.
Patients were initially categorized into survivors and non-survivors based on ROSC and 28-day survival status. Furthermore, 28-day survivors were stratified into two subgroups based on their neurological status using the Cerebral Performance Category (CPC) score. Favorable neurological outcome was defined as CPC 1-2 (good to moderate cerebral performance with independence), while CPC 3-5 (severe disability, coma, or death) constituted unfavorable outcome.
Prior to the initiation of the study, a standardized and pre-piloted data collection form was developed based on current literature to ensure consistency and reproducibility. During the study period, patient data were initially recorded by board-certified emergency medicine specialists who were on duty in the ED at the time of each patient's arrival. These attending physicians were directly responsible for patient management and completed the data forms either during the resuscitation process or immediately thereafter. All physicians involved in data entry were blinded to the study hypothesis. Subsequently, all collected data were extracted, cross-checked, and verified for accuracy and completeness by an emergency medicine specialist with eight years of clinical experience, who was also blinded to the study hypothesis.
Patient data were obtained from multiple sources, including hospital's automated systems and ED's archives, prehospital EMS reports, and the national digital healthcare database of Türkiye (e-Nabız), which was used to verify survival status and neurological outcomes at 28 days.
Collected data includes, demographics (age, sex), comorbidities (hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease, or malignancy), and prehospital variables such as whether the cardiac arrest was witnessed, whether bystander CPR was performed, the time from collapse to the initiation of CPR, the time from collapse to EMS arrival, the durations of no-flow (time without CPR) and low-flow (time with CPR but no ROSC), and the initial cardiac rhythm, categorized as ventricular fibrillation or pulseless ventricular tachycardia (VF/pVT), asystole, or pulseless electrical activity (PEA). The airway management method used by EMS was also recorded, including BVM, SGD, or ETI. Other recorded interventions included prehospital defibrillation, epinephrine administration (including total dose), and the use of mechanical chest compression devices. Whether ROSC was achieved in the field prior to ED arrival was also documented.
On arrival to the ED, clinical examination findings included the patient's body temperature, the Glasgow Coma Score (if measurable), the presence or absence of pupillary light reflex, and the requirement for vasopressor support within the first hour.
Laboratory data obtained upon admission included hematological parameters such as white blood cell count (WBC), hemoglobin level, platelet count, mean platelet volume (MPV), neutrophil count, monocyte count, and eosinophil count. Biochemical measurements included creatinine, urea, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, potassium, chloride, calcium, and troponin-I levels. Arterial blood gas analysis results included pH, partial pressure of carbon dioxide (pCO₂), bicarbonate, lactate concentration, carboxyhemoglobin percentage, and methemoglobin percentage.
Clinical outcomes, including ROSC, 28-day survival or mortality, and neurological status, were also recorded.
Patients' demographics, initial rhythm, prehospital intubation status, and hematological, biochemical, and blood gas parameters on admission were compared to identify factors associated with 28-day survival and neurological status between the groups. Independent predictors of survival were determined via multivariate logistic regression analysis of variables that significantly differed between survivors and non-survivors.
- Being tested
- Demographics, Comorbidities, Prehospital Variables, Hematological Parameters, Biochemical Parameters
- Keywords
- OHCA, short-term survival, endotracheal intubation, cardiopulmonary resuscitation, neurological outcomes
- 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 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.
Hematological ParametersDiagnostic test
These included white blood cell count (WBC), hemoglobin level, platelet count, mean platelet volume (MPV), and differential counts such as neutrophils, monocytes, and eosinophils.
Biochemical ParametersDiagnostic test
Measurements included creatinine, urea, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, potassium, chloride, calcium, and troponin-I levels.
Arterial Blood Gas ParametersDiagnostic test
The primary clinical outcomes recorded for each patient included return of spontaneous circulation (ROSC), 28-day survival or mortality, and neurological status, which was later assessed using the Cerebral Performance Category (CPC) scale.
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Survivors 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: Hematological Parameters; Diagnostic Test: Biochemical Parameters; Diagnostic Test: Arterial Blood Gas Parameters | |
| Non-survivors | Non-survivors had passed away within 28 days following the cardiac arrest event. Receives: Other: Demographics; Other: Comorbidities; Other: Prehospital Variables; Diagnostic Test: Hematological Parameters; Diagnostic Test: Biochemical Parameters; Diagnostic Test: Arterial Blood Gas Parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Return of Spontaneous Circulation (ROSC)
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.
Number of Participants Alive at Day 28
Survival was assessed as the patient being alive at 28 days following the cardiac arrest event.
Measured: Assessed within the first 20 minutes after emergency department admission.
Number of Participants with Favorable Neurological Outcome (CPC 1-2) at Day 28
Neurological outcome was determined using the Cerebral Performance Category (CPC) scale, with a CPC score of 1 or 2 representing a favorable neurological outcome, and scores from 3 to 5 considered unfavorable, reflecting severe neurological disability, coma, or death.
Measured: Assessed within the first 20 minutes after emergency department admission.
Secondary outcomes (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: Assessed within the first 20 minutes after emergency department admission.
Comparison of Favorable Neurological Outcome Rates at Day 28 Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not
The investigators evaluate the impact of prehospital endotracheal intubation (ETI) on neurological outcomes at Day 28 following cardiac arrest. Neurological status will be assessed using the Cerebral Performance Category (CPC) scale. A CPC score of 1 or 2 will be considered a favorable neurological outcome. Participants will be categorized into two groups based on whether or not they received ETI in the prehospital setting.
Measured: Assessed within the first 20 minutes after emergency department admission.
Correlation Between Admission Serum Lactate Level and 28-Day Survival
The investigators evaluate the correlation between serum lactate level at emergency department admission and 28-day survival status following out-of-hospital cardiac arrest. Lactate will be measured in mmol/L using a standard arterial blood gas analyzer.
Measured: Assessed within the first 20 minutes after emergency department admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Az, Haseki Training and Research Hospital
- Investigators
- Adem Az, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023159
- Sponsor's protocol ID
- 01-2023
- Acronym
- OHCAstd
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Stored in non-publicly avaliable Avaliable on request
Publications
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 29486039Wang 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 30167699Strnad M, Borovnik Lesjak V, Jerot P, Esih M. Prehospital Predictors of Survival in Patients with Out-of-Hospital Cardiac Arrest. Medicina (Kaunas). 2023 Sep 26;59(10):1717. doi: 10.3390/medicina59101717.
PubMed 37893434Brooks SC, Clegg GR, Bray J, Deakin CD, Perkins GD, Ringh M, Smith CM, Link MS, Merchant RM, Pezo-Morales J, Parr M, Morrison LJ, Wang TL, Koster RW, Ong MEH; International Liaison Committee on Resuscitation. Optimizing Outcomes After Out-of-Hospital Cardiac Arrest With Innovative Approaches to Public-Access Defibrillation: A Scientific Statement From the International Liaison Committee on Resuscitation. Circulation. 2022 Mar 29;145(13):e776-e801. doi: 10.1161/CIR.0000000000001013. Epub 2022 Feb 15.
PubMed 35164535Soholm H, Wachtell K, Nielsen SL, Bro-Jeppesen J, Pedersen F, Wanscher M, Boesgaard S, Moller JE, Hassager C, Kjaergaard J. Tertiary centres have improved survival compared to other hospitals in the Copenhagen area after out-of-hospital cardiac arrest. Resuscitation. 2013 Feb;84(2):162-7. doi: 10.1016/j.resuscitation.2012.06.029. Epub 2012 Jul 13.
PubMed 22796541Bro-Jeppesen J, Kjaergaard J, Horsted TI, Wanscher MC, Nielsen SL, Rasmussen LS, Hassager C. The impact of therapeutic hypothermia on neurological function and quality of life after cardiac arrest. Resuscitation. 2009 Feb;80(2):171-6. doi: 10.1016/j.resuscitation.2008.09.009. Epub 2008 Dec 25.
PubMed 19111378
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Clinical Factors and Laboratory Parameters Associated With Short-Term Survival in Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT07023159
- Acronym / sponsor ID
- OHCAstd / 01-2023
- Keywords
- OHCA, short-term survival, endotracheal intubation, cardiopulmonary resuscitation, neurological outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aimed to identify clinical and laboratory predictors of return of spontaneous circulation (ROSC), 28-day survival, and favorable neurological outcomes in adult patients experiencing out-of-hospital cardiac arrest (OHCA) and brought to the emergency department (ED) by emergency medical services (EMS). Specifically, the prognostic value of hematologic, biochemical, and blood gas parameters on admission was assessed for ROSC, 28-day survival, and favorable neurological recovery. Additionally, the study investigated the influence of key patient-centered and prehospital variables, including demographic features, initial cardiac rhythm, and the timeliness and type of cardiopulmonary resuscitation (CPR), defibrillation, and airway interventions, on overall survival and neurological status.
Detailed description
This prospective, observational, and cross-sectional study was conducted in the ED of a tertiary urban hospital between May 2023 and May 2024. Adult patients (aged ≥18 years) who experienced OHCA and received attempted resuscitation by EMS personnel were screened for eligibility. All patients received advanced cardiac life support (ACLS) in accordance with the 2021 European Resuscitation Council (ERC) and 2020 American Heart Association (AHA) guidelines.
Patients were initially categorized into survivors and non-survivors based on ROSC and 28-day survival status. Furthermore, 28-day survivors were stratified into two subgroups based on their neurological status using the Cerebral Performance Category (CPC) score. Favorable neurological outcome was defined as CPC 1-2 (good to moderate cerebral performance with independence), while CPC 3-5 (severe disability, coma, or death) constituted unfavorable outcome.
Prior to the initiation of the study, a standardized and pre-piloted data collection form was developed based on current literature to ensure consistency and reproducibility. During the study period, patient data were initially recorded by board-certified emergency medicine specialists who were on duty in the ED at the time of each patient's arrival. These attending physicians were directly responsible for patient management and completed the data forms either during the resuscitation process or immediately thereafter. All physicians involved in data entry were blinded to the study hypothesis. Subsequently, all collected data were extracted, cross-checked, and verified for accuracy and completeness by an emergency medicine specialist with eight years of clinical experience, who was also blinded to the study hypothesis.
Patient data were obtained from multiple sources, including hospital's automated systems and ED's archives, prehospital EMS reports, and the national digital healthcare database of Türkiye (e-Nabız), which was used to verify survival status and neurological outcomes at 28 days.
Collected data includes, demographics (age, sex), comorbidities (hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease, or malignancy), and prehospital variables such as whether the cardiac arrest was witnessed, whether bystander CPR was performed, the time from collapse to the initiation of CPR, the time from collapse to EMS arrival, the durations of no-flow (time without CPR) and low-flow (time with CPR but no ROSC), and the initial cardiac rhythm, categorized as ventricular fibrillation or pulseless ventricular tachycardia (VF/pVT), asystole, or pulseless electrical activity (PEA). The airway management method used by EMS was also recorded, including BVM, SGD, or ETI. Other recorded interventions included prehospital defibrillation, epinephrine administration (including total dose), and the use of mechanical chest compression devices. Whether ROSC was achieved in the field prior to ED arrival was also documented.
On arrival to the ED, clinical examination findings included the patient's body temperature, the Glasgow Coma Score (if measurable), the presence or absence of pupillary light reflex, and the requirement for vasopressor support within the first hour.
Laboratory data obtained upon admission included hematological parameters such as white blood cell count (WBC), hemoglobin level, platelet count, mean platelet volume (MPV), neutrophil count, monocyte count, and eosinophil count. Biochemical measurements included creatinine, urea, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, potassium, chloride, calcium, and troponin-I levels. Arterial blood gas analysis results included pH, partial pressure of carbon dioxide (pCO₂), bicarbonate, lactate concentration, carboxyhemoglobin percentage, and methemoglobin percentage.
Clinical outcomes, including ROSC, 28-day survival or mortality, and neurological status, were also recorded.
Patients' demographics, initial rhythm, prehospital intubation status, and hematological, biochemical, and blood gas parameters on admission were compared to identify factors associated with 28-day survival and neurological status between the groups. Independent predictors of survival were determined via multivariate logistic regression analysis of variables that significantly differed between survivors and non-survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: Demographics, Other: Comorbidities, Other: Prehospital Variables, Diagnostic Test: Hematological Parameters, Diagnostic Test: Biochemical Parameters, Diagnostic Test: Arterial Blood Gas ParametersSurvivors were defined as the patient being alive at 28 days following the cardiac arrest event. |
| Non-survivors | – | Other: Demographics, Other: Comorbidities, Other: Prehospital Variables, Diagnostic Test: Hematological Parameters, Diagnostic Test: Biochemical Parameters, Diagnostic Test: Arterial Blood Gas ParametersNon-survivors had passed away within 28 days following the cardiac arrest event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 420 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 May 2023 and May 2024.
Key inclusion criteria (1 listed)
- This study included 420 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 May 2023 and May 2024.
Key exclusion criteria (5 listed)
- Patients aged < 18 years
- Patients with in-hospital cardiac arrest
- Patients who have suffered cardiac arrest due to major trauma, drowning, drug overdose, or known terminal illness
- Patients with active hematologic malignancy
- Patients with incomplete data regarding primary outcomes or admission laboratory tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DemographicsThe demographic profile of each patient was documented, including age and sex, to examine potential associations with survival and neurological outcomes. | Other | Non-survivors, Survivors |
| ComorbiditiesData 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. | Other | Non-survivors, Survivors |
| Prehospital VariablesSeveral prehospital factors were evaluated, including whether the cardiac arrest was witnessed, whether bystander 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. | Other | Non-survivors, Survivors |
| Hematological ParametersThese included white blood cell count (WBC), hemoglobin level, platelet count, mean platelet volume (MPV), and differential counts such as neutrophils, monocytes, and eosinophils. | Diagnostic test | Non-survivors, Survivors |
| Biochemical ParametersMeasurements included creatinine, urea, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, potassium, chloride, calcium, and troponin-I levels. | Diagnostic test | Non-survivors, Survivors |
| Arterial Blood Gas ParametersThe primary clinical outcomes recorded for each patient included return of spontaneous circulation (ROSC), 28-day survival or mortality, and neurological status, which was later assessed using the Cerebral Performance Category (CPC) scale. | Diagnostic test | Non-survivors, Survivors |
Primary outcome
Number of Participants with Return of Spontaneous Circulation (ROSC)
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.
Number of Participants Alive at Day 28
Time frame: Assessed within the first 20 minutes after emergency department admission.
Survival was assessed as the patient being alive at 28 days following the cardiac arrest event.
Number of Participants with Favorable Neurological Outcome (CPC 1-2) at Day 28
Time frame: Assessed within the first 20 minutes after emergency department admission.
Neurological outcome was determined using the Cerebral Performance Category (CPC) scale, with a CPC score of 1 or 2 representing a favorable neurological outcome, and scores from 3 to 5 considered unfavorable, reflecting severe neurological disability, coma, or death.
3 secondary outcomes
Comparison of 28-Day Survival Rates Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not
Time frame: Assessed within the first 20 minutes after emergency department admission.
Comparison of Favorable Neurological Outcome Rates at Day 28 Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not
Time frame: Assessed within the first 20 minutes after emergency department admission.
Correlation Between Admission Serum Lactate Level and 28-Day Survival
Time frame: Assessed within the first 20 minutes after emergency department admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 29486039Jabre 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.
- Results publication: PubMed 30167699Wang 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.
- Results publication: PubMed 37893434Strnad M, Borovnik Lesjak V, Jerot P, Esih M. Prehospital Predictors of Survival in Patients with Out-of-Hospital Cardiac Arrest. Medicina (Kaunas). 2023 Sep 26;59(10):1717. doi: 10.3390/medicina59101717.
- Results publication: PubMed 35164535Brooks SC, Clegg GR, Bray J, Deakin CD, Perkins GD, Ringh M, Smith CM, Link MS, Merchant RM, Pezo-Morales J, Parr M, Morrison LJ, Wang TL, Koster RW, Ong MEH; International Liaison Committee on Resuscitation. Optimizing Outcomes After Out-of-Hospital Cardiac Arrest With Innovative Approaches to Public-Access Defibrillation: A Scientific Statement From the International Liaison Committee on Resuscitation. Circulation. 2022 Mar 29;145(13):e776-e801. doi: 10.1161/CIR.0000000000001013. Epub 2022 Feb 15.
- Results publication: PubMed 22796541Soholm H, Wachtell K, Nielsen SL, Bro-Jeppesen J, Pedersen F, Wanscher M, Boesgaard S, Moller JE, Hassager C, Kjaergaard J. Tertiary centres have improved survival compared to other hospitals in the Copenhagen area after out-of-hospital cardiac arrest. Resuscitation. 2013 Feb;84(2):162-7. doi: 10.1016/j.resuscitation.2012.06.029. Epub 2012 Jul 13.
- Results publication: PubMed 19111378Bro-Jeppesen J, Kjaergaard J, Horsted TI, Wanscher MC, Nielsen SL, Rasmussen LS, Hassager C. The impact of therapeutic hypothermia on neurological function and quality of life after cardiac arrest. Resuscitation. 2009 Feb;80(2):171-6. doi: 10.1016/j.resuscitation.2008.09.009. Epub 2008 Dec 25.
- Individual participant dataSharing planned: No. Stored in non-publicly avaliable Avaliable on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adem Az principal investigator
Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
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 1 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 Jun 2025. 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?
Number of Participants with Return of Spontaneous Circulation (ROSC) (time frame: Assessed within the first 20 minutes after emergency department admission.). The study lists 3 primary outcomes in all. 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 NCT07023159, which also lists 6 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 Jun 2025.