The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- Oxygen Desaturation Index 4% (ODI4%)
研究概览
简要总结
Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.
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
Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
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
- •for the study are:
- •Participant has ability to provide written informed consent
- •Participants aged ≥18 years old
- •Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
- •Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months
- •Participants with a previously documented AHI ≥ 5/hr
- •Participants with a recently (≤ 12 months ago) reviewed EPAP setting
排除标准
- •for the study are:
- •Participants are not compliant on NIPPV (e.g. < 4 hr/night)
- •Participants who are pregnant
- •Participants on oxygen therapy ≥5 L/min
- •Participants with an invasive interface (e.g. tracheostomy)
- •Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation
- •Participants who are acutely ill, medically complicated or who are medically unstable
- •Participants in whom NIPPV therapy is otherwise medically contraindicated
- •Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- •Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
- •Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma.
- •Participant does not comprehend English
- •Participant is unable or unwilling to provide written informed consent
- •Participant is physically and/or mentally unable to comply with the protocol
- •Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator
研究组 & 干预措施
iVAPS with AutoEPAP
This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night.
干预措施: Astral (Device)
iVAPS with manual EPAP
This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night.
干预措施: Astral (Device)
结局指标
主要结局
Oxygen Desaturation Index 4% (ODI4%)
时间窗: Overnight, up to 8 hrs on nights 1 and 2
Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP
次要结局
- Apnea Hypopnea Index (AHI)(Overnight, up 8 hrs on night 1 and 2)
- Arterial Carbon Dioxide (PCO2)(Overnight, up 8 hrs on night 1 and 2)
- Sleep Efficiency (%)(Overnight, up to 8 hrs on nights 1 and 2)
- Nadir Arterial Oxygen Saturation (SpO2)(Overnight, up 8 hrs on night 1 and 2)