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

Heart Failure Clinical Trial

— IC-E-PPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414126
• Other study ID #: 2014 A1907-40
• Status: Completed
• Phase: N/A
• Start date: July 10, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: April 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Aspiration

Intervention

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

Device:
• CPAP

Locations

Country	Name	City	State
France	Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Philips Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oesophageal pressure during spontaneous breathing and during continuous positive airway pressure		up to 5 days
Primary	trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure		up to 5 days
Secondary	Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure		up to 5 days
Secondary	Polysomnography during spontaneous breathing		up to 5 days
Secondary	sleep questionnaire		up to 5 days