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Completed
NCT02262182
Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® After Cardiac Surgery in the Management of Postoperative Atelectasis
Conditions: Pulmonary Atelectasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Nantes University Hospital
Location: Nantes Universitary Hospital Saint-Herblain
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02262182). StuddyBuddy aggregates publicly available trial information.