Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

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.
    

Intervention name(s): Effect of CPAP on respiratory work and cardiac function indices during wakefulness; Effect of CPAP on respiratory work and cardiac function indices during wakefulness; Effect of CPAP on respiratory work and cardiac function indices during wakefulness; CPAP
Intervention type(s): Other; Other; Other; Device
Intervention description(s): 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; 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; 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Heart failure; child; work of breathing; cardiac function; sleep; polysomnography; CPAP