Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness
* Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness
* Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Children with dilated cardiomyopathy with an ejection fraction<br> | Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness<br>* Comparison of three periods of 3 hours st period: Spontaneous breathing for 10 minutes nd period: CPAP for 10 minutes rd period: Spontaneous breathing for 10 minutes to check the return to baseline. After each period, the following parameters will be recorded during 5 minutes: oesogastric pressures air flow gas exchange right and left cardiac function Patients > 6 years old will assess their dyspnea on a visual analogue scale<br>Device: CPAP<br> <br> |
| Active Comparator: Children with univentricular congenital heart disease<br> | Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness<br>* Comparison of three periods of 3 hours st period: Spontaneous breathing for 10 minutes nd period: CPAP for 10 minutes rd period: Spontaneous breathing for 10 minutes to check the return to baseline. After each period, the following parameters will be recorded during 5 minutes: oesogastric pressures air flow gas exchange right and left cardiac function Patients > 6 years old will assess their dyspnea on a visual analogue scale<br>Device: CPAP<br> <br> |
| Active Comparator: Children with left valvulopathy<br> | Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness<br>* Comparison of three periods of 3 hours st period: Spontaneous breathing for 10 minutes nd period: CPAP for 10 minutes rd period: Spontaneous breathing for 10 minutes to check the return to baseline. After each period, the following parameters will be recorded during 5 minutes: oesogastric pressures air flow gas exchange right and left cardiac function Patients > 6 years old will assess their dyspnea on a visual analogue scale<br>Device: CPAP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oesophageal pressure during spontaneous breathing and during continuous positive airway pressure |  | up to 5 days | 
| trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure |  | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| sleep questionnaire |  | up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, child, work of breathing, cardiac function, sleep, polysomnography, CPAP