跳至主要内容
临床试验/NCT07023159
NCT07023159已完成不适用

Predicting Clinical Factors and Laboratory Parameters Associated With Short-Term Survival in Out-of-Hospital Cardiac Arrest

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2023年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
327
试验地点
1
主要终点
Number of Participants with Return of Spontaneous Circulation (ROSC)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Number of Participants with Return of Spontaneous Circulation (ROSC)

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Comparison of 28-Day Survival Rates Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not(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(Assessed within the first 20 minutes after emergency department admission.)
  • Correlation Between Admission Serum Lactate Level and 28-Day Survival(Assessed within the first 20 minutes after emergency department admission.)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adem Az

Principal Investigator

Haseki Training and Research Hospital

研究点 (1)

Loading locations...

相似试验

Predicting 28-Day Survival in OHCA Patients | 临床试验