Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® After Cardiac Surgery in the Management of Postoperative Atelectasis
- Conditions
- Pulmonary Atelectasis
- Interventions
- Other: KP groupOther: KM group
- Registration Number
- NCT02262182
- Lead Sponsor
- Nantes University Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KP group KP group PEP delivery by EzPAP® device with manual chest physiotherapy . KM group KM group Manual chest physiotherapy only;
- Primary Outcome Measures
Name Time Method Radiological atelectasis score Day 2 post-inclusion This score was first described by Pasquina P et al in 2004
- Secondary Outcome Measures
Name Time Method SpO2/FiO2 ratio Days 1, 2 and 3 post inclusion This ratio is measured before and after session
Radiological atelectasis score Days 1 and 3 post-inclusion This score was first described by Pasquina P et al in 2004
Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session Days 1, 2 and 3 post inclusion This respiratory function assessment is performed in a qualitative way
Dyspnea evaluation Days 1, 2 and 3 post inclusion Dyspnea is measured with a visual analogue scale before and after session
Inspiratory pressure measurement Days 2 and 3 post inclusion This measurement (so called sniff test) is assessed with MicroRPM device before and after session
Pain evaluation Days 1, 2 and 3 post inclusion Pain is measured with a visual analogue scale before and after session
Vesicular murmur intensity 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
Assessment of patient satisfaction and tolerance of EzPAP device Day 3 post inclusion A questionnaire of 10 answer with semi-quantitative scale
Cardiac and respiratory rate Days 1, 2 and 3 post inclusion Measurement performed at the same time as SPO2 (patients are monitored)
Trial Locations
- Locations (1)
Nantes Universitary Hospital
🇫🇷St-Herblain, France