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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmon

Brief 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.

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: Radiological atelectasis score [ Time Frame: Day 2 post-inclusion ]

This score was first described by Pasquina P et al in 2004


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiological atelectasis score [ Time Frame: Days 1 and 3 post-inclusion ]
    This score was first described by Pasquina P et al in 2004
  • SpO2/FiO2 ratio [ Time Frame: Days 1, 2 and 3 post inclusion ]
    This ratio is measured before and after session
  • Cardiac and respiratory rate [ Time Frame: Days 1, 2 and 3 post inclusion ]
    Measurement performed at the same time as SPO2 (patients are monitored)
  • Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session [ Time Frame: Days 1, 2 and 3 post inclusion ]
    This respiratory function assessment is performed in a qualitative way
  • Dyspnea evaluation [ Time Frame: Days 1, 2 and 3 post inclusion ]
    Dyspnea is measured with a visual analogue scale before and after session
  • Pain evaluation [ Time Frame: Days 1, 2 and 3 post inclusion ]
    Pain is measured with a visual analogue scale before and after session
  • Vesicular murmur intensity [ Time Frame: Days 1, 2 and 3 post inclusion ]
    Vesicular murmur absent = 0, reduce = 1, present and normal = 2 Intensity is measured with an electronic stethoscope before and after session
  • Inspiratory pressure measurement [ Time Frame: Days 2 and 3 post inclusion ]
    This measurement (so called sniff test) is assessed with MicroRPM device before and after session
  • Assessment of patient satisfaction and tolerance of EzPAP device [ Time Frame: Day 3 post inclusion ]
    A questionnaire of 10 answer with semi-quantitative scale


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: October 7, 2014
Date Started: November 2014
Date Completion:
Last Updated: September 28, 2016
Last Verified: September 2016