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

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Aspiration

• NCT number: NCT02414126
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: July 10, 2015
• Completion date: July 30, 2017