Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Adult Patients With Respiratory Failure or Respiratory Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 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
The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.
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
- Single (Participant)
盲法说明
Subject was blinded to device identity
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 85 years
- •Weight > 20 kg (44 lbs)
- •Respiratory failure or respiratory insufficiency
- •Ability to cooperate with the investigators
排除标准
- •An endotracheal tube or tracheostomy in place
- •Hemodynamic 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
- •Inability or unwillingness to provide Informed Consent
- •PaO2 < 50 mmHg
研究组 & 干预措施
V60 Mask, Then Conventional Mask
Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD
干预措施: noninvasive ventilator (Device)
Conventional Mask, Then V60 Mask
Comparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD.
干预措施: noninvasive ventilator (Device)
结局指标
主要结局
Breathing comfort
时间窗: 0, 15, and 30 minutes
次要结局
- Physiological variables(0, 15, and 30 minutes)