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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
80
Nantes Universitary Hospital
Saint-Herblain, France
Radiological atelectasis score
This score was first described by Pasquina P et al in 2004
Time frame: Day 2 post-inclusion
Radiological atelectasis score
This score was first described by Pasquina P et al in 2004
Time frame: Days 1 and 3 post-inclusion
SpO2/FiO2 ratio
This ratio is measured before and after session
Time frame: Days 1, 2 and 3 post inclusion
Cardiac and respiratory rate
Measurement performed at the same time as SPO2 (patients are monitored)
Time frame: 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
Time frame: Days 1, 2 and 3 post inclusion
Dyspnea evaluation
Dyspnea is measured with a visual analogue scale before and after session
Time frame: Days 1, 2 and 3 post inclusion
Pain evaluation
Pain is measured with a visual analogue scale before and after session
Time frame: 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
Time frame: 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
Time frame: Days 2 and 3 post inclusion
Assessment of patient satisfaction and tolerance of EzPAP device
A questionnaire of 10 answer with semi-quantitative scale
Time frame: Day 3 post inclusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.