Skip to main content
OpenTrials
Completed

NCT Number: NCT02262182

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes Universitary Hospital

Saint-Herblain, 44805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KP group

Other

Other names: Associated to manual chest physiotherapy, patients receive twice a day 4 periods of PEP delivery by EzPAP® device during 25 respiratory cycles.

KM group

Other

Other names: Patients of the control group benefit only from manual chest physiotherapy twice a day

Primary outcomes

  1. Radiological atelectasis score

    Time frame: Day 2 post-inclusion

    This score was first described by Pasquina P et al in 2004

Secondary outcomes

  1. Radiological atelectasis score

    Time frame: Days 1 and 3 post-inclusion

    This score was first described by Pasquina P et al in 2004

  2. SpO2/FiO2 ratio

    Time frame: Days 1, 2 and 3 post inclusion

    This ratio is measured before and after session

  3. Cardiac and respiratory rate

    Time frame: Days 1, 2 and 3 post inclusion

    Measurement performed at the same time as SPO2 (patients are monitored)

  4. Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session

    Time frame: Days 1, 2 and 3 post inclusion

    This respiratory function assessment is performed in a qualitative way

  5. Dyspnea evaluation

    Time frame: Days 1, 2 and 3 post inclusion

    Dyspnea is measured with a visual analogue scale before and after session

  6. Pain evaluation

    Time frame: Days 1, 2 and 3 post inclusion

    Pain is measured with a visual analogue scale before and after session

  7. Vesicular murmur intensity

    Time frame: 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

  8. Inspiratory pressure measurement

    Time frame: Days 2 and 3 post inclusion

    This measurement (so called sniff test) is assessed with MicroRPM device before and after session

  9. Assessment of patient satisfaction and tolerance of EzPAP device

    Time frame: Day 3 post inclusion

    A questionnaire of 10 answer with semi-quantitative scale

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: PEPKIN

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.