Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® After Cardiac Surgery in the Management of Postoperative Atelectasis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmonary Atelectasis in Patients After Cardiac Surgery

Conditions
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Pulmonary Atelectasis

Intervention / Treatment
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* Other: KP group
* Other: KM group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted in ICU after cardiac surgery by sternotomy with cardiopulmonary bypass presenting a pulmonary atelectasis after extubation, diagnosed by chest X-ray in postoperative period (day1 to day 2). Patients over 18 years of age Informed patient Exclusion Criteria: Cardiac arrhythmia Hemodynamic instability (mean blood pressure < 65 mmHg or > 95 mmHg) Respiratory rate > 35/min Undrained pneumothorax Predictable trachea intubation or emergent surgery Patient oral refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KP group<br>PEP delivery by EzPAP® device with manual chest physiotherapy . | Other: KP group<br> <br> * Other names: Associated to manual chest physiotherapy, patients receive twice a day 4 periods of PEP delivery by EzPAP® device during 25 respiratory cycles.;|
| Placebo Comparator: KM group<br>Manual chest physiotherapy only; | Other: KM group<br> <br> * Other names: Patients of the control group benefit only from manual chest physiotherapy twice a day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological atelectasis score | This score was first described by Pasquina P et al in 2004 | Day 2 post-inclusion | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery