Effects of an Oxymizer Pendant Cannula Versus a Conventional Nasal Cannula During Endurance Shuttle Walk Test (ESWT) in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Endurance shuttle walk test distance
研究概览
简要总结
Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking.
详细描述
Patients will be recruited during an inpatient pulmonary rehabilitation program. They will perform three shuttle walk tests on three consecutive days (see below). While performing those tests, the patient's prescribed oxygen flow rate is applicated either through the conventional nasal cannula (CNC) or the Oxymizer.On the first day, patients perform an incremental shuttle walk test to determine maximum walking speed using a conventional nasal cannula.
On two consecutive days, patients will perform two endurance shuttle walk tests at 85% of the maximum incremental shuttle walk test speed. Supplemental oxygen will be provided via nasal cannula at the prescribed oxygen flow rate. Patients will be randomly assigned to perform one test with the Oxymizer and the other one with a conventional nasal cannula.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •firmed diagnosis of idiopathic pulmonary fibrosis
- •indication for supplemental oxygen therapy during exercise
- •referred to an inpatient rehabilitation program at the Schön Klinik Berchtesgadener Land
排除标准
- •cardiovascular diseases that influence the patient's physical performance
- •orthopedic comorbidities that prevent the patient from performing an incremental or endurance shuttle walk test
- •carbon dioxide pressure above 45 mmHg at rest and ambient air
研究组 & 干预措施
First ESWT with Oxymizer, second ESWT with CNC
Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the Oxymizer and the second ESWT with a conventional nasal cannula (CNC).
干预措施: Oxymizer® pendant nasal cannula (Device)
First ESWT with Oxymizer, second ESWT with CNC
Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the Oxymizer and the second ESWT with a conventional nasal cannula (CNC).
干预措施: conventional nasal cannula (Device)
First ESWT with CNC, second ESWT with Oxymizer
Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.
干预措施: Oxymizer® pendant nasal cannula (Device)
First ESWT with CNC, second ESWT with Oxymizer
Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.
干预措施: conventional nasal cannula (Device)
结局指标
主要结局
Endurance shuttle walk test distance
时间窗: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Distance patients walk during an endurance shuttle walk test
次要结局
- heart rate(at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test)
- carbon dioxide pressure(at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test)
- oxygen saturation(at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test)
- breathing frequency(at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test)
- time to desaturation(From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes)
研究者
Klaus Kenn
Prof. Dr. med.
Schön Klinik Berchtesgadener Land