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

Primary Purpose

Pulmonary Atelectasis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

KP group

KM group

About this trial

This is an interventional supportive care trial for Pulmonary Atelectasis focused on measuring Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nantes Universitary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KP group

KM group

Arm Description

PEP delivery by EzPAP® device with manual chest physiotherapy .

Manual chest physiotherapy only;

Outcomes

Primary Outcome Measures

Radiological atelectasis score

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

Secondary Outcome Measures

Radiological atelectasis score

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

SpO2/FiO2 ratio

This ratio is measured before and after session

Cardiac and respiratory rate

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

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

Dyspnea evaluation

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

Pain evaluation

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

Vesicular murmur intensity

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

Inspiratory pressure measurement

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

Assessment of patient satisfaction and tolerance of EzPAP device

A questionnaire of 10 answer with semi-quantitative scale

Full Information

NCT ID

NCT02262182

First Posted

October 7, 2014

Last Updated

September 28, 2016

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02262182

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Atelectasis

Keywords

Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KP group

Arm Type

Experimental

Arm Description

PEP delivery by EzPAP® device with manual chest physiotherapy .

Arm Title

KM group

Arm Type

Placebo Comparator

Arm Description

Manual chest physiotherapy only;

Intervention Type

Other

Intervention Name(s)

KP group

Other Intervention Name(s)

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

Intervention Type

Other

Intervention Name(s)

KM group

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Radiological atelectasis score

Description

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

Time Frame

Day 2 post-inclusion

Secondary Outcome Measure Information:

Title

Radiological atelectasis score

Description

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

Time Frame

Days 1 and 3 post-inclusion

Title

SpO2/FiO2 ratio

Description

This ratio is measured before and after session

Time Frame