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

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

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 Overview

• Status: Completed
• Conditions: Pulmonary Atelectasis
• Intervention / Treatment: Other: KP group; Other: KM group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • St-Herblain, France, 44805
    • Nantes Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KP group; PEP delivery by EzPAP® device with manual chest physiotherapy .	Other: KP group; Other Names: Associated to manual chest physiotherapy, patients receive twice a day 4 periods of PEP delivery by EzPAP® device during 25 respiratory cycles.
Placebo Comparator: KM group; Manual chest physiotherapy only;	Other: KM group; Other Names: Patients of the control group benefit only from manual chest physiotherapy twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological atelectasis score	This score was first described by Pasquina P et al in 2004	Day 2 post-inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological atelectasis score	This score was first described by Pasquina P et al in 2004	Days 1 and 3 post-inclusion
SpO2/FiO2 ratio	This ratio is measured before and after session	Days 1, 2 and 3 post inclusion
Cardiac and respiratory rate	Measurement performed at the same time as SPO2 (patients are monitored)	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	Days 1, 2 and 3 post inclusion
Dyspnea evaluation	Dyspnea is measured with a visual analogue scale before and after session	Days 1, 2 and 3 post inclusion
Pain evaluation	Pain is measured with a visual analogue scale before and after session	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	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	Days 2 and 3 post inclusion
Assessment of patient satisfaction and tolerance of EzPAP device	A questionnaire of 10 answer with semi-quantitative scale	Day 3 post inclusion

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: RC14_0033