Clinical trial NCT02262182: Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® After Cardiac Surgery in the Management of Postoperative Atelectasis
Official title: Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmonary Atelectasis in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Keywords: Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Radiological atelectasis score
timeFrame: Day 2 post-inclusion
Secondary outcomes:
measure: Radiological atelectasis score
timeFrame: Days 1 and 3 post-inclusion
measure: SpO2/FiO2 ratio
timeFrame: Days 1, 2 and 3 post inclusion
measure: Cardiac and respiratory rate
timeFrame: Days 1, 2 and 3 post inclusion
measure: Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session
timeFrame: Days 1, 2 and 3 post inclusion
measure: Dyspnea evaluation
timeFrame: Days 1, 2 and 3 post inclusion
measure: Pain evaluation
timeFrame: Days 1, 2 and 3 post inclusion
measure: Vesicular murmur intensity
timeFrame: Days 1, 2 and 3 post inclusion
measure: Inspiratory pressure measurement
timeFrame: Days 2 and 3 post inclusion
measure: Assessment of patient satisfaction and tolerance of EzPAP device
timeFrame: Day 3 post inclusion
Other outcomes:
Locations:
city: St-Herblain
country: France
facility: Nantes Universitary Hospital
Study officials:
References: