NCT05267418终止不适用
Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance in Patients With Desaturating Chronic Lung Disease: a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dyspnea score
研究概览
简要总结
The main purpose of this study is to evaluate the effects of automated oxygen administration (FreeO2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participant was not inform about what kind of oxygen support was provided during exercise
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
- •One of them
- •Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) < 80% predicted and FEV1/forced vital capacity (FVC) ratio < 0.7)
- •Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography
- •Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure > 25 mm Hg at right heart catheterization
- •Cystic fibrosis, as diagnosed by a positive sweat test (>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.
- •AND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test < 88%
排除标准
- •Exacerbation of the primary lung disease in the past 8 weeks
- •Exercise limiting diseases other than the primary lung disease.
- •Not reaching the target dyspnea score during the walking tests.
- •Stage 1 pulmonary sarcoidosis
- •History of syncope on exertion
- •SpO2 with effort less than 90% despite the use of 6 L of O2 per minute
- •Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)
- •Disabling or severe rheumatological or neurological condition
- •Participation in a pulmonary rehabilitation program within the last year
- •Patients with multi-resistant bacteria
结局指标
主要结局
Dyspnea score
时间窗: At the end of the 3 minute-constant speed shuttle test (CSST) (3 minutes), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)
Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)
次要结局
- Endurance time duration of the Endurance Shuttle Walking Test (EWST)(Duration in (mm:ss) of Endurance Shuttle Walking Test (ESWT), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow))
- Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)(From the beginning to the end of the Endurance Shuttle Walking Test (ESWT) which will be done on 3 testing days, with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow)
研究者
Francois Maltais
Principal Investigator
Laval University
研究点 (2)
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