The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients With Respiratory Failure on Long-term Oxygen Therapy During Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- The percentage of time spent with SpO2 <90% during sleep (%)
研究概览
简要总结
Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia) especially during sleep which may be harmful. In order to overcome this, the investigators have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent intermittent hypoxia during sleep in patients already on long-term oxygen.
详细描述
Long-term oxygen therapy (LTOT) improves survival in patients with chronic obstructive pulmonary disease (COPD) and severe persistent hypoxia. LTOT is prescribed at a fixed-flow rate with the aim of maintaining a partial pressure of oxygen greater than or equal to 8 kilopascals (kPa). However, a number of studies have demonstrated that patients on home LTOT experience episodes of intermittent hypoxia during rest, activities and especially sleep. Simply increasing the oxygen flow rate at night can relieve this hypoxia but at the expense of hyperoxia with its detrimental effects of hypercapnia and respiratory acidosis. Therefore, a more targeted approach is needed to oxygen delivery. The investigators have devised an auto-titrating oxygen system (intelligent oxygen therapy [iO2Ts]) which delivers variable flow oxygen to maintain a pre-set specific oxygen saturation ( SpO2) target. The system can avoid the dual hazards of hypoxia and hyperoxia and potentially optimise LTOT.
This study will be investigating whether the iO2Ts can reduce intermittent hypoxia during sleep compared to usual fixed flow oxygen in patients on LTOT. Nineteen patients will be recruited to undergo two sleep studies each on two different nights; one on their usual LTOT flow rate and one of the iO2Ts. During both sleep studies, all participants will have full polysomnography, oxygen and transcutaneous carbon dioxide monitoring. The primary outcome will the percentage of time spent with SpO2 < 90% during sleep.
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
Participant not aware using iO2T or Fixed flow oxygen
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
- •On or eligible for long-term oxygen therapy
排除标准
- •Nocturnal use of non-invasive ventilation (NIV) or continuous positive airways pressure (CPAP)
- •A diagnosis of obstructive sleep apnoea
- •A diagnosis of a neuromuscular disease
- •Daytime partial pressure of carbon dioxide > 8.0 kPa
- •Inability to consent for the study
- •Exacerbation of the underlying lung disease or chest infection in the previous 4 weeks
- •Severe co-morbidities
- •Patients with a tracheostomy
- •Long-term oxygen therapy flow rate ≥ 4 litre per minute
- •Inability to understand the English language
结局指标
主要结局
The percentage of time spent with SpO2 <90% during sleep (%)
时间窗: 10 hours in bed
The difference in percentage time spent at SpO2 less than 90% during sleeping usual LTOT and iO2T (measured as %)
次要结局
- The mean transcutaneous carbon dioxide level during sleep (measured in kPa)(10 hours in bed)
- The peak transcutaneous carbon dioxide level during sleep measures in kPa(10 hours in bed)
- Sleep quality as measured on a visual analogue scale (0 - 100mm).(10 hours in bed)
- Total Sleep time(10 hours during sleep)
- The percentage of time spent with SpO2 >96% during sleep (%)(10 hours in bed)
- The mean sleep SpO2(10 hours during sleep)
- Sleep efficiency(10 hours in bed)