Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure (IC-E-PPC)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Heart Failure

Treatments: Device: CPAP; Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02414126

2014 A1907-40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 8 months to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Children with dilated cardiomyopathy with an ejection fraction

Active Comparator group

Treatment:

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

Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Children with univentricular congenital heart disease

Active Comparator group

Treatment:

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

Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Children with left valvulopathy

Active Comparator group

Treatment:

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

Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness