AzTrials
AzTrials

Pulmonary AtelectasisPEPKINNCT02262182

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

A study testing KP group and KM group in people with Pulmonary Atelectasis, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Atelectasis
What is being tested?
KP group and KM group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteFrance
Study dates
Nov 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nantes Universitary Hospital

    Saint-Herblain, 44805

Other trials in France

About this study

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

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.

Being tested
KP group, KM group
Keywords
Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KP groupOther

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

  • KM groupOther

    Also called Patients of the control group benefit only from manual chest physiotherapy twice a day

Study groups in NCT02262182
Study groupRoleWhat they receive
KP groupExperimentalPEP delivery by EzPAP® device with manual chest physiotherapy .
Receives: Other: KP group
KM groupPlacebo comparatorManual chest physiotherapy only;
Receives: Other: KM group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiological atelectasis score

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

    Measured: Day 2 post-inclusion

Secondary outcomes (9)

  1. Radiological atelectasis score

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

    Measured: Days 1 and 3 post-inclusion

  2. SpO2/FiO2 ratio

    This ratio is measured before and after session

    Measured: Days 1, 2 and 3 post inclusion

  3. Cardiac and respiratory rate

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

    Measured: Days 1, 2 and 3 post inclusion

  4. 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

    Measured: Days 1, 2 and 3 post inclusion

  5. Dyspnea evaluation

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

    Measured: Days 1, 2 and 3 post inclusion

  6. Pain evaluation

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

    Measured: Days 1, 2 and 3 post inclusion

  7. Vesicular murmur intensity

    Vesicular murmur absent = 0, reduce = 1, present and normal = 2 Intensity is measured with an electronic stethoscope before and after session

    Measured: Days 1, 2 and 3 post inclusion

  8. Inspiratory pressure measurement

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

    Measured: Days 2 and 3 post inclusion

  9. Assessment of patient satisfaction and tolerance of EzPAP device

    A questionnaire of 10 answer with semi-quantitative scale

    Measured: Day 3 post inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02262182
Sponsor's protocol ID
RC14_0033
Acronym
PEPKIN
Status last verified
Sep 2016
First submitted
7 Oct 2014
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • Baneton S, Dauvergne JE, Gouillet C, Cartron E, Volteau C, Nicolet J, Corne F, Rozec B. Effect of Active Physiotherapy With Positive Airway Pressure on Pulmonary Atelectasis After Cardiac Surgery: A Randomized Controlled Study. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1668-1676. doi: 10.1053/j.jvca.2023.05.043. Epub 2023 May 30.

    PubMed 37331837

Questions about this trial

What is this clinical trial studying?

A study testing KP group and KM group in people with Pulmonary Atelectasis, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological atelectasis score (time frame: Day 2 post-inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02262182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in