Clinical trial NCT02414126: Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
Official title: Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
child
work of breathing
cardiac function
sleep
polysomnography
CPAP
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2015-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
timeFrame: up to 5 days
measure: trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
timeFrame: up to 5 days
Secondary outcomes:
measure: Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure
timeFrame: up to 5 days
measure: Polysomnography during spontaneous breathing
timeFrame: up to 5 days
measure: sleep questionnaire
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
Study officials:
References: