PRecision-Controlled Ventilation to Enhance Cardiac Arrest Intervention and Survival IN CPR: A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 852
- 试验地点
- 3
- 主要终点
- Return of Spontaneous Circulation (ROSC)
研究概览
简要总结
Cardiac arrest is a life-threatening emergency that requires immediate treatment with cardiopulmonary resuscitation (CPR). While chest compressions circulate blood, manual ventilation provides oxygen to the patient. Current CPR guidelines recommend specific ventilation rates and tidal volumes, but studies show that clinicians often deliver too much or too little ventilation due to a lack of monitoring tools, potentially reducing the effectiveness of CPR and impacting survival.
The PRECISION-CPR study is a multi-center, randomized controlled trial designed to evaluate whether using real-time feedback devices to precisely control ventilation during CPR can improve patient outcomes. Adult patients experiencing in-hospital cardiac arrest will be randomized to receive either standard manual ventilation guided by clinician experience or precision-controlled ventilation tailored to the patient's predicted body weight using real-time monitoring devices.
The primary outcome of the study will be return of spontaneous circulation (ROSC). Secondary outcomes will include survival to hospital discharge, neurological recovery, and other clinical measures. By addressing the limitations of current ventilation practices, this study aims to generate evidence to guide future resuscitation guidelines and improve survival rates after cardiac arrest.
详细描述
The PRECISION-CPR trial is a prospective, multi-center, randomized controlled trial evaluating the effect of precision-controlled ventilation on outcomes during cardiopulmonary resuscitation (CPR) in adult in-hospital cardiac arrest. The study aims to determine whether the use of real-time feedback devices to guide tidal volume (6-8 mL/kg predicted body weight) and respiratory rate (10 breaths per minute) improves return of spontaneous circulation (ROSC) and other clinical outcomes.
Participants are randomized 1:1 to either:
Intervention Group: Manual ventilation guided by real-time feedback device providing continuous tidal volume and respiratory rate feedback during CPR.
Control Group: Manual ventilation performed per standard care without feedback, with the same devices used in blinded mode to record but not display ventilation data.
Ventilation parameters are recorded breath-by-breath. Hemodynamic and clinical variables (e.g., heart rate, end-tidal CO₂) are obtained from the electronic medical record and time-synchronized with ventilation data. Data are collected in REDCap and monitored by a central coordinating center. A Data Safety Monitoring Board oversees safety, protocol adherence, and interim analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older) with in-hospital cardiac arrest receiving manual ventilation via bag-mask or artificial airway
排除标准
- •Inability to estimate predicted body weight (e.g., extreme body habitus or lack of height data).
- •Patients receiving Extracorporeal Membrane Oxygenation (ECMO).
- •Known pregnancy.
研究组 & 干预措施
Precision-Controlled Ventilation with Real-Time Feedback
Patients will receive manual ventilation during CPR using real-time feedback devices (EOlife) to guide tidal volume (6-8 mL/kg predicted body weight) and ventilation rate (10 breaths per minute) delivery, ensuring adherence to guideline-recommended ventilation parameters.
干预措施: Precision-Controlled Ventilation with Real-Time Feedback (Device)
Standard of Care Ventilation During CPR
Patients will receive manual ventilation during CPR per standard practice without real-time feedback, using clinician judgment for tidal volume (visible chest rise) and ventilation rate, consistent with American Heart Association guidelines.
干预措施: Standard Manual Ventilation During CPR (Other)
结局指标
主要结局
Return of Spontaneous Circulation (ROSC)
时间窗: During resuscitation (up to 60 minutes after cardiac arrest onset)
Documented presence of a palpable pulse and measurable blood pressure during resuscitation after initiation of CPR.
次要结局
- Survival to Hospital Discharge(Through hospital discharge (up to 28 days after enrollment))
- Neurological Status at Hospital Discharge(At time of hospital discharge (up to 28 days after CPR event))
- Time to Return of Spontaneous Circulation (ROSC)(From initiation of CPR to termination of resuscitation efforts (up to 60 minutes after CPR initiation))
- Duration of Mechanical Ventilation(From intubation until extubation or hospital discharge, up to 60 days.)
- Length of ICU Stay(From ICU admission until ICU discharge, up to 60 days.)
- New Occurrence of Pneumothorax During CPR(During resuscitation (up to 60 minutes after cardiac arrest onset))
研究者
Jie Li
Professor
Rush University Medical Center