NCT00817804已完成不适用
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric Patients With Respiratory Failure or Respiratory Insufficiency
Respironics, California, Inc.2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Breathing Comfort
研究概览
简要总结
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
详细描述
This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 7 years and < 18 years
- •Weight > 20 kg (44 lbs)
- •Respiratory failure or respiratory insufficiency
- •Ability to cooperate with the investigators
- •Designated adult able to provide Informed Consent
排除标准
- •An endotracheal tube or tracheostomy in place
- •Hemodynamically instability
- •Prolonged apnea
- •Inability to maintain the airway
- •A recent history of cardiac and or respiratory arrest
- •Acute hemorrhage
- •Multiple organ system failure
- •Undrained pneumothorax
- •High risk for aspiration
- •Metastatic or terminal cancer
- •Do-not-resuscitate orders
- •Inability to clear respiratory secretions
- •Inability to fit a mask
- •Facial surgery, trauma, or deformity
- •Upper gastrointestinal or airway surgery
- •Pregnancy
- •Refractory delirium
- •PaO2 < 50 mmHg on present settings
- •Designee unable or unwilling to provide Informed Consent
结局指标
主要结局
Breathing Comfort
时间窗: 30 minutes
Comfort on visual analog scale 0 - 100, 0 is best
次要结局
- Saturation of Arterial Oxygen(30 minutes)
- Respiratory Rate(30 minutes)
- Minute Ventilation(30 minutes)
- Heart Rate(30 minutes)
- Blood Pressure(30 minutes)
研究者
研究点 (2)
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