Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The study starts with the measurement during wakefulness of
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with dilated cardiomyopathy with an ejection fraction | Active Comparator |
| |
| Children with univentricular congenital heart disease | Active Comparator |
| |
| Children with left valvulopathy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effect of CPAP on respiratory work and cardiac function indices during wakefulness | Other | Comparison of three periods of 3 hours
After each period, the following parameters will be recorded during 5 minutes:
Patients > 6 years old will assess their dyspnea on a visual analogue scale |
| Measure | Description | Time Frame |
|---|---|---|
| oesophageal pressure during spontaneous breathing and during continuous positive airway pressure | up to 5 days | |
| trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure | up to 5 days | |
| Polysomnography during spontaneous breathing | up to 5 days | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris) | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33991896 | Result | Amaddeo A, Khraiche D, Khirani S, Meot M, Jais JP, Bonnet D, Fauroux B. Continuous positive airway pressure improves work of breathing in pediatric chronic heart failure. Sleep Med. 2021 Jul;83:99-105. doi: 10.1016/j.sleep.2021.04.003. Epub 2021 Apr 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Effect of CPAP on respiratory work and cardiac function indices during wakefulness | Other | Comparison of three periods of 3 hours
After each period, the following parameters will be recorded during 5 minutes:
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 | Other | Comparison of three periods of 3 hours
After each period, the following parameters will be recorded during 5 minutes:
Patients > 6 years old will assess their dyspnea on a visual analogue scale |
|
| CPAP | Device |
|
| sleep questionnaire |
| up to 5 days |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided