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临床试验/NCT07524881
NCT07524881已完成不适用

Association of Prehospital Endotracheal Intubation With 28-Day Survival and Neurological Outcomes 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 297 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
297
试验地点
1
主要终点
28 day-survival rate

研究概览

简要总结

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.

详细描述

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.

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

  • 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

排除标准

  • 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

研究组 & 干预措施

No ETI attempt

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

干预措施: Comorbidities (Other)

Survivors

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

干预措施: Demographics (Other)

No ETI attempt

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

干预措施: 28-day survival (Other)

Survivors

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

干预措施: Comorbidities (Other)

Failed ETI attempt

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

干预措施: Comorbidities (Other)

No ETI attempt

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

干预措施: Neurological outcome (Other)

Survivors

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

干预措施: Prehospital Variables (Other)

Survivors

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

干预措施: Arterial Blood Gas Parameters (Diagnostic Test)

Non-survivors

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

干预措施: Demographics (Other)

Non-survivors

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

干预措施: Comorbidities (Other)

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).

干预措施: Neurological outcome (Other)

Failed ETI attempt

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

干预措施: Demographics (Other)

Non-survivors

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

干预措施: Prehospital Variables (Other)

Non-survivors

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

干预措施: Arterial Blood Gas Parameters (Diagnostic Test)

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).

干预措施: Demographics (Other)

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).

干预措施: Comorbidities (Other)

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).

干预措施: Prehospital Variables (Other)

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).

干预措施: Arterial Blood Gas Parameters (Diagnostic Test)

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).

干预措施: 28-day survival (Other)

Failed ETI attempt

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

干预措施: Prehospital Variables (Other)

Failed ETI attempt

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

干预措施: Arterial Blood Gas Parameters (Diagnostic Test)

Failed ETI attempt

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

干预措施: 28-day survival (Other)

Failed ETI attempt

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

干预措施: Neurological outcome (Other)

No ETI attempt

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

干预措施: Demographics (Other)

No ETI attempt

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

干预措施: Prehospital Variables (Other)

No ETI attempt

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

干预措施: Arterial Blood Gas Parameters (Diagnostic Test)

结局指标

主要结局

28 day-survival rate

时间窗: 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.

次要结局

  • 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)

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)

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