Intraosseous Versus Intravenous Vascular Access During Resuscitation Following Out-of-Hospital Cardiac Arrest: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,356
- 试验地点
- 1
- 主要终点
- return of spontaneous circulation (ROSC)
研究概览
简要总结
- Background:
Intraosseous (IO) access is a new, fast, safe and efficient route of rescue of critically ill patients. Studies found drug pharmacokinetics and pharmacodynamics of IO are similar to IV route. Compared with IV and CVC, IO is time-consuming, easy to grasp, and has high operation success rate. Guidelines recommend IO when the establishment of vascular access is difficult or impossible.
Recent animal studies suggest that IO access have better ventricular fibrillation termination rates, ROSC rates and survival compared with IV route. However, recent retrospective clinical studies found that IO versus IV treatment was associated with a lower likelihood of ROSC and hospitalization. How routes of vascular access influence clinical outcomes after OHCA merits multicenter randomized controlled trial. We suppose IO versus IV treatment is associated with a higher likelihood of ROSC and hospital and discharge survival. 2. Materials and methods:
Study design This study is a prospective, open, two-arm, multicenter randomized controlled trial. The study will be conducted by 22 medical centers or affiliated hospitals in China. We will enroll nearly 2356 OHCA patients by the eligibility and exclusion criteria during January 2020 to December 2022. All of the patients will be randomized to one of 2 routes of vascular access: tibial intraosseous or peripheral intravenous. Other treatment measures of two groups refer to 2015 AHA Advanced Cardiovascular Life Support guidelines.
Statistical analysis Intention-to-treat analysis (ITT) and per-protocol set (PPS) sensitivity analysis will be conducted in our study. Categorical variables are presented as counts and percentages, and differences are analyzed using the χ2 test. Continuous variables are presented as means with standard deviations or median (interquartile range [IQR]), and analysis is done by the Student t test or the Mann-Whitney U test according to normal or non-normal distributions. 3. Sample Size Calculation Set the following assumptions: alpha 0.025, beta 80%, clinically significant difference of 5% and 25% ROSC rate for both arms. Assuming the sample has an equal number of subjects in each arm, the study need to include at least 1178 subjects per arm to reach statistical significance.
详细描述
- Background:
Successful vascular access is critical for the treatment of acute and critically ill patients, especially those with cardiac arrest. For cardiac arrest patients, besides high-quality chest compressions and defibrillation, timely use of rescue drugs is also important. This requires early vascular access during chest compressions. Clinical studies and animal experiments indicate that 1 min delay of administration of antiarrhythmic drugs will increase the risk of adverse outcome, also found that the time interval from cardiac arrest to the first dose of rescue medication is closely related to the return of spontaneous circulation (ROSC) and prognosis.
Because of the circulatory failure of patients with cardiac arrest, peripheral venous network often collapses, which makes it more difficult to develop vascular access. In addition, central venous catheterization (CVC) often takes an experienced physician at least 5-10 min, and it may affect resuscitation.
Intraosseous (IO) access is a new, fast, safe and efficient route of rescue of critically ill patients. Animal and clinical studies found drug pharmacokinetics and pharmacodynamics of IO are similar to IV route. Compared with IV and CVC, IO is time-consuming, easy to grasp, and has high operation success rate. European Resuscitation Council (ERC) 2015 guidelines recommend IO when the establishment of vascular access is difficult or impossible.
Recent animal studies suggest that IO access have better ventricular fibrillation termination rates, ROSC rates and survival compared with IV route. However, recent retrospective clinical studies found that IO versus IV treatment was associated with a lower likelihood of ROSC and hospitalization. How routes of vascular access influence clinical outcomes after OHCA merits multicenter randomized controlled trial. We suppose IO versus IV treatment is associated with a higher likelihood of ROSC and hospital and discharge survival. 2. Materials and methods:
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
- None
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
- •Out of hospital cardiac arrest patients with 18 years or more
排除标准
- •Traumatic cardiopulmonary arrest with an indication of withholding of resuscitation, including:
- •trauma victims with injuries that are obviously incompatible with life, such as decapitation or hemicorporectomy;
- •victims of either blunt or penetrating trauma when there is evidence of prolonged cardiac arrest, including rigor mortis or dependent lividity;
- •blunt trauma patient who, on the arrival of emergency medical services (EMS) personnel, is found to be apneic, pulseless, and without organized electrocardiographic activity;
- •penetrating trauma patients who, on the arrival of EMS personnel, is found to be pulseless and apneic and there are no other signs of life, including spontaneous movement, electrocardiographic activity, and pupillary response;
- •Vascular access has been established before admission;
- •Return of spontaneous circulation before first attempt to establish vascular access;
- •Quit resuscitation;
- •Patients with contraindications of intraosseous access;
- •infection of insertion site, such as skin and soft tissue infections, osteomyelitis;
- •integrity damage of the target bone, such as fractures, artificial limbs, etc;
- •blood supply or return of the target bone is significantly affected, e.g. arteriovenous rupture;
- •burns of insertion site;
- •intraosseous attempt in same insertion site within 24 h;
- •compartment syndrome exists in same insertion site;
- •unclear anatomical structures of insertion site, such as obesity, malformations;
- •patients with severe bone diseases, such as imperfect osteogenesis, osteoporosis;
- •patients with right to left cardiac shunt (e.g. Tetralogy of Fallot, pulmonary atresia, etc).
结局指标
主要结局
return of spontaneous circulation (ROSC)
时间窗: within 24 hours
ROSC can be identified with the following three conditions: 1. arterial pulse can be reached; 2. effective ECG rhythm; 3. systolic blood pressure \> 60 mmHg (1 mm Hg = 0.133 kPa);.
次要结局
- first attempt success(within 24 hours)
- initial epinephrine administration interval(within 24 hours)
- overall success(within 24 hours)
- initial access interval(within 24 hours)
- sustained ROSC(24 hours)