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

Pulmonary Atelectasis Clinical Trial

— PEPKIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262182
• Other study ID #: RC14_0033
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: September 28, 2016
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Intervention

Other:
• KP group

• KM group

Locations

Country	Name	City	State
France	Nantes Universitary Hospital	St-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological atelectasis score	This score was first described by Pasquina P et al in 2004	Day 2 post-inclusion	No
Secondary	Radiological atelectasis score	This score was first described by Pasquina P et al in 2004	Days 1 and 3 post-inclusion	No
Secondary	SpO2/FiO2 ratio	This ratio is measured before and after session	Days 1, 2 and 3 post inclusion	No
Secondary	Cardiac and respiratory rate	Measurement performed at the same time as SPO2 (patients are monitored)	Days 1, 2 and 3 post inclusion	No
Secondary	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	Days 1, 2 and 3 post inclusion	No
Secondary	Dyspnea evaluation	Dyspnea is measured with a visual analogue scale before and after session	Days 1, 2 and 3 post inclusion	No
Secondary	Pain evaluation	Pain is measured with a visual analogue scale before and after session	Days 1, 2 and 3 post inclusion	No
Secondary	Vesicular murmur intensity	Vesicular murmur absent = 0, reduce = 1, present and normal = 2 Intensity is measured with an electronic stethoscope before and after session	Days 1, 2 and 3 post inclusion	No
Secondary	Inspiratory pressure measurement	This measurement (so called sniff test) is assessed with MicroRPM device before and after session	Days 2 and 3 post inclusion	No
Secondary	Assessment of patient satisfaction and tolerance of EzPAP device	A questionnaire of 10 answer with semi-quantitative scale	Day 3 post inclusion	Yes