Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During 30 Sec STST in Chronic Obstructivepulmonary Disease Patients, Without Resting Hypoxemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- cerebral oxygenation at the prefrontal lobe
研究概览
简要总结
It is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec Sit-To-Stand Test (STST) in chronic obstructive pulmonary disease patients, without resting hypoxemia. After an initial clinical assessment, patients preform the 30sec STST under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. Measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of COPD, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio <0.7, and 2) resting arterial oxygen partial pressure >60 mmHg, according to recent (within a week) arterial blood gases assessment.
排除标准
- •recent COPD exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot)
研究组 & 干预措施
Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD
Oxygen supplementation via nasal cannula at a rate of 3 lit/min
干预措施: Oxygen (Drug)
Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD
Medical air supplementation via nasal cannula at a rate of 3 lit/min
干预措施: medical air (Drug)
结局指标
主要结局
cerebral oxygenation at the prefrontal lobe
时间窗: For 2 and a half minutes (one minute of rest, 30 seconds during Sit-To-Stand Test and one minute of recovery after the test)
Near infrared spectroscopy will be utilised to assess cerebral oxygenation, by measuring oxygenated hemoglobin (O2Hb) at the prefrontal lobe, in COPD patients
次要结局
- Number of repetitions during Sit-To-Stand Test(From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds.)
- Severity of dyspnea(At the end of the 30 second Sit-To-Stand Test)
- Severity of fatigue(At the end of the 30 seconds Sit-To-Stand Test)
研究者
Afroditi Boutou
Consultant in Pulmonary Medicine
George Papanicolaou Hospital