Back to resultsEvaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure (IC-E-PPC)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, child, work of breathing, cardiac function, sleep, polysomnography, CPAP
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).
Sites / Locations
- Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Children with dilated cardiomyopathy with an ejection fraction
Children with univentricular congenital heart disease
Children with left valvulopathy
Arm Description
Outcomes
Primary Outcome Measures
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
Secondary Outcome Measures
Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure
Polysomnography during spontaneous breathing
sleep questionnaire
Full Information
NCT ID
NCT02414126
First Posted
February 24, 2015
Last Updated
April 27, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Philips Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02414126
Brief Title
Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
Acronym
IC-E-PPC
Official Title
Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2015 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Philips Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, child, work of breathing, cardiac function, sleep, polysomnography, CPAP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children with dilated cardiomyopathy with an ejection fraction
Arm Type
Active Comparator
Arm Title
Children with univentricular congenital heart disease
Arm Type
Active Comparator
Arm Title
Children with left valvulopathy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Effect of CPAP on respiratory work and cardiac function indices during wakefulness
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Effect of CPAP on respiratory work and cardiac function indices during wakefulness
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Effect of CPAP on respiratory work and cardiac function indices during wakefulness
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
CPAP
Primary Outcome Measure Information:
Title
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
Time Frame
up to 5 days
Title
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure
Time Frame
up to 5 days
Title
Polysomnography during spontaneous breathing
Time Frame
up to 5 days
Title
sleep questionnaire
Time Frame
up to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
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Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
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