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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing the Effectiveness of Lung Expansion Therapy in Adult Human Subjects

NCT02892773

Atelectasis

COMPLETED NA

Effect of EPAP Device on Emphysema and Lung Bullae

NCT04742114

Emphysema Bullous Disease Lung

UNKNOWN NA

Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy

NCT03083379

Ventilation Breathing Atelectasis

COMPLETED NA

Esophageal Pressure Measurements During One-lung Ventilation

NCT04725318

Surgery One-lung Ventilation

TERMINATED

Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury

NCT00127491

Acute Lung Injury Acute Respiratory Distress Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Atelectasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KP group

PEP delivery by EzPAP® device with manual chest physiotherapy .

Group Type EXPERIMENTAL

KP group

Intervention Type OTHER

KM group

Manual chest physiotherapy only;

Group Type PLACEBO_COMPARATOR

KM group

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KP group

Intervention Type OTHER

KM group

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Associated to manual chest physiotherapy, patients receive twice a day 4 periods of PEP delivery by EzPAP® device during 25 respiratory cycles. Patients of the control group benefit only from manual chest physiotherapy twice a day

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No