Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
研究概览
简要总结
Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these patients.
The aim of the study is to analyze the work of breathing and objective and subjective sleep quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the work of breathing and improve cardiac output during wakefulness.
详细描述
The study starts with the measurement during wakefulness of
- the breathing pattern and work of breathing
- and cardiac function during 5 min after 10 min of stable and calm spontaneous breathing (SB) Then the same measurement are made during 5 min after 10 min of stable and calm breathing during non-invasive CPAP Then a third measurement is made of
- the breathing pattern and work of breathing
- and cardiac function during 5 min after 10 min a stable and calm SB
Polysomnography is then performed during the following night during SB in order to assess objective sleep quality.
Subjective sleep quality is assessed on the following morning in children > 6 years of age by validated sleep questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 8 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A child with HF and having:
- •Dilated cardiomyopathy with an ejection fraction <45%
- •Univentricular congenital heart disease
- •Left ventricular valvulopathy
- •Age 8 months to 17 years
- •Signed informed consent by the owner (s) of parental authority and investigator
- •Patient affiliated to a social security scheme or entitled (excluding MEAs)
- •Comparison of results depending on the status T21 / T21 not.
排除标准
- •HF with use of inotropic drugs during the last 30 days.
- •Contra indication to CPAP or inability to maintain the airway or adequately remove phlegm, risk of aspiration of gastric contents, acute sinusitis or diagnosis of otitis media, epistaxis, hypotension.
- •Associated pathology may be responsible alone an obstructive apnea (ENT or maxillofacial malformation pathology, abnormalities of the upper airway, obesity with BMI z-score> 2), a central apnea syndrome (Chiari malformation), or alveolar hypoventilation (neuromuscular disease, cystic fibrosis or bronchopulmonary dysplasia).
结局指标
主要结局
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
时间窗: up to 5 days
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
时间窗: up to 5 days
次要结局
- sleep questionnaire(up to 5 days)
- Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure(up to 5 days)
- Polysomnography during spontaneous breathing(up to 5 days)