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Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac surgery. Classically, the treatment of these patients is based on manual chest physiotherapy. Our objective is to evaluate the interest of association of positive end expiratory delivery sessions with the EzPAP® device. We perform a prospective monocentric, open label trial. Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are included. They benefit from manual chest therapy and are randomised to receive or not positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of this treatment on atelectasis radiological score after 2 days of treatment. The secondary endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of ventilatory function, respiratory & cardiac rate, pain, inspiratory pressure (sniff test), patient satisfaction, duration of intensive care unit (ICU) and hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KP group | Experimental | PEP delivery by EzPAP® device with manual chest physiotherapy . |
|
| KM group | Placebo Comparator | Manual chest physiotherapy only; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP group | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiological atelectasis score | This score was first described by Pasquina P et al in 2004 | Day 2 post-inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological atelectasis score | This score was first described by Pasquina P et al in 2004 | Days 1 and 3 post-inclusion |
| SpO2/FiO2 ratio | This ratio is measured before and after session |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Universitary Hospital | Saint-Herblain | 44805 | France |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| KM group | Other |
|
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| Days 1, 2 and 3 post inclusion |
| Cardiac and respiratory rate | Measurement performed at the same time as SPO2 (patients are monitored) | Days 1, 2 and 3 post inclusion |
| Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session | This respiratory function assessment is performed in a qualitative way | Days 1, 2 and 3 post inclusion |
| Dyspnea evaluation | Dyspnea is measured with a visual analogue scale before and after session | Days 1, 2 and 3 post inclusion |
| Pain evaluation | Pain is measured with a visual analogue scale before and after session | Days 1, 2 and 3 post inclusion |
| Vesicular murmur intensity | Vesicular murmur absent = 0, reduce = 1, present and normal = 2 Intensity is measured with an electronic stethoscope before and after session | Days 1, 2 and 3 post inclusion |
| Inspiratory pressure measurement | This measurement (so called sniff test) is assessed with MicroRPM device before and after session | Days 2 and 3 post inclusion |
| Assessment of patient satisfaction and tolerance of EzPAP device | A questionnaire of 10 answer with semi-quantitative scale | Day 3 post inclusion |