Pulmonary Atelectasis
Conditions
Keywords
Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery
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.
Interventions
OTHERKP group
OTHERKM group
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological atelectasis score | Day 2 post-inclusion | This score was first described by Pasquina P et al in 2004 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological atelectasis score | Days 1 and 3 post-inclusion | This score was first described by Pasquina P et al in 2004 |
| SpO2/FiO2 ratio | Days 1, 2 and 3 post inclusion | This ratio is measured before and after session |
| Cardiac and respiratory rate | 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 | 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 |
| 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 |
| Inspiratory pressure measurement | 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 | Day 3 post inclusion | A questionnaire of 10 answer with semi-quantitative scale |
Countries
France
Outcome results
None listed