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

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ClinicalTrials.gov Identifier: NCT02414126
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness Device: CPAP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
Actual Study Start Date : July 10, 2015
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Children with dilated cardiomyopathy with an ejection fraction Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Comparison of three periods of 3 hours

  1. st period: Spontaneous breathing for 10 minutes
  2. nd period: CPAP for 10 minutes
  3. 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
Active Comparator: Children with univentricular congenital heart disease Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Comparison of three periods of 3 hours

  1. st period: Spontaneous breathing for 10 minutes
  2. nd period: CPAP for 10 minutes
  3. 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
Active Comparator: Children with left valvulopathy Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Comparison of three periods of 3 hours

  1. st period: Spontaneous breathing for 10 minutes
  2. nd period: CPAP for 10 minutes
  3. 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



Primary Outcome Measures :
  1. oesophageal pressure during spontaneous breathing and during continuous positive airway pressure [ Time Frame: up to 5 days ]
  2. trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure [ Time Frame: up to 5 days ]

Secondary Outcome Measures :
  1. Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure [ Time Frame: up to 5 days ]
  2. Polysomnography during spontaneous breathing [ Time Frame: up to 5 days ]
  3. sleep questionnaire [ Time Frame: up to 5 days ]


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Ages Eligible for Study:   8 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414126


Locations
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France
Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Philips Healthcare

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02414126     History of Changes
Other Study ID Numbers: 2014 A1907-40
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart failure
child
work of breathing
cardiac function
sleep
polysomnography
CPAP
Additional relevant MeSH terms:
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Respiratory Aspiration
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes