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

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02262182
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: KP group
  • Other: KM group
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
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 Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Radiological atelectasis score [Day 2 post-inclusion]

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

    Secondary Outcome Measures

    1. Radiological atelectasis score [Days 1 and 3 post-inclusion]

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

    2. SpO2/FiO2 ratio [Days 1, 2 and 3 post inclusion]

      This ratio is measured before and after session

    3. Cardiac and respiratory rate [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 [Days 1, 2 and 3 post inclusion]

      This respiratory function assessment is performed in a qualitative way

    5. Dyspnea evaluation [Days 1, 2 and 3 post inclusion]

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

    6. Pain evaluation [Days 1, 2 and 3 post inclusion]

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

    7. Vesicular murmur intensity [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 [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 [Day 3 post inclusion]

      A questionnaire of 10 answer with semi-quantitative scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nantes Universitary Hospital St-Herblain France 44805

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT02262182
    Other Study ID Numbers:
    • RC14_0033
    First Posted:
    Oct 10, 2014
    Last Update Posted:
    Sep 29, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Nantes University Hospital
    Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery
    Additional relevant MeSH terms:
    Pulmonary Atelectasis

    Study Results

    No Results Posted as of Sep 29, 2016