Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours
研究概览
简要总结
This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.
详细描述
Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
排除标准
- •Age less than 1 month or greater than 5 years
- •Positive for COVID-19
- •Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
- •Unresponsiveness (GCS 8 or less)
- •Hypotension as defined as a systolic blood pressure less than 5th percentile for age
- •Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
- •Non-English speaking parent
结局指标
主要结局
Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours
时间窗: Four hours
Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (\>5 minutes) removals or disruptions.
次要结局
- Oxygen Saturation(4 hours)
- Respiratory Rate(4 hours)
- Heart Rate(4 hours)
- Systolic Blood Pressure(4 hours)