Effects of an Automatic Oxygen Titration vs. Constant Oxygen Flow Rates During Daily Activities in Patients After SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change of oxygen saturation during the endurance shuttle walk Tests
研究概览
简要总结
With the progression of the SARS-CoV-2 pandemic there's an increasing number of patients recovering from COVID19. Some of these patients still experience hypoxemia and therefore are still in need of a long-term oxygen therapy (LTOT), usually provided as a constant-flow. However, during a patient's daily activities, oxygenation levels may vary and the same constant flow may not be suitable for all tasks. Studies in COPD patients suggest that an automatic oxygen titration, which adjusts the oxygen flow automatically according to a patient's blood oxygen levels to prevent desaturations, could be beneficial compared to a constant oxygen titration during exercise.
So far there are no studies available that directly compare the automatic oxygen titration with the patient's prescribed constant oxygen flow in patients with hypoxemia after SARS-CoV-2 infection during activities of daily life. Therefore, the primary outcome of this study is to investigate the effects of an automatic oxygen titration (O2matic, Denmark) in comparison to constant oxygen flow rates as prescribed according to guidelines.
详细描述
Rationale
After an infection with SARS-CoV-2, some patients still experience hypoxemia even after being discharged from the hospital. Long-term oxygen therapy (LTOT) is then used to increase the patients blood oxygen level and prolong the time spent within the SpO2 target range, decreasing the probability of severe hypoxemia or at least lowering the time spent in this severe hypoxemia and all in all enhance the patient's endurance. A prescription for LTOT is usually given for constant flow rates which might vary during day- and night use.
This study is a randomized, controlled cross-over trial. Its aim is to investigate the effects of an automatic oxygen titration in patients after SARS-CoV-2 infection on the blood oxygen saturation level during activities of daily life (walking). Secondary, the effects of using an automatic titration on endurance, pCO2 blood level as well as heart rate and breathing frequency are compared to using the prescribed constant flow oxygen therapy.
Design:
Each patient undergoes a series of shuttle walk tests. After an initial incremental shuttle walk test (ISWT) to determine the patient's maximum walking speed, the patient undergoes 2 endurance shuttle walk tests (ESWTs) at 85% of the maximum walking speed. One of these ESWTs is performed with the prescribed constant oxygen flow, the other with the O2matic automatic oxygen titration in a random order.
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
- Double (Participant, Investigator)
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
- •validated COVID19 disease in case history
- •hypoxemia (PO2 < 55 mmHg) under room air conditions (rest or during exercise) or SpO2 <88% during exercise
- •already established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
排除标准
- •acute infection
- •cardiovascular diseases that limit physical fitness
- •orthopedic diseases preventing the patient from undergoing the walking tests
结局指标
主要结局
Change of oxygen saturation during the endurance shuttle walk Tests
时间窗: Day 2, 3
SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
次要结局
- Change of Endurance time (s)(Day 2, 3, 4)
- Change of transcutaneous pCO2 during ESWTs(Day 2, 3)
- Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk tests(Day 2, 3)
- Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk tests(Day 2,3)
- Change of respiratory rate during ESWTs(Day 2, 3)
- Change of heart rate during ESWTs and stair walking tests(Day 2, 3, 4)
- Patients preference due to oxygen delivery system(Day 3)
- Change of time to desaturation (SpO2 ≤ 90%) and to severe desaturation (SpO2 ≤ 85%) during ESWTs and Stair Walking Tests(Day 2, 3, 4)
- Change of number of stairs(Day 4)
研究者
Prof. Dr. Andreas Rembert Koczulla
Head of Pneumological Department
Schön Klinik Berchtesgadener Land