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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Pulmonary Atelectasis

Treatments: Other: KM group; Other: KP group

Study type: Interventional

Funder types: Other

Identifiers

NCT02262182

RC14_0033

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

KP group

Experimental group

Description:

PEP delivery by EzPAP® device with manual chest physiotherapy .

Treatment:

Other: KP group

KM group

Placebo Comparator group

Description:

Manual chest physiotherapy only;

Treatment:

Other: KM group