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

NCT02262182 | Completed

• 1 other identifier: RC14_0033
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Atelectasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Radiological atelectasis score

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

  Day 2 post-inclusion

Secondary Outcomes (9)

• Radiological atelectasis score

  Days 1 and 3 post-inclusion

• SpO2/FiO2 ratio

  Days 1, 2 and 3 post inclusion

• Cardiac and respiratory rate

  Days 1, 2 and 3 post inclusion

• 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

• Dyspnea evaluation

  Days 1, 2 and 3 post inclusion

Study Arms (2)

KP group

EXPERIMENTAL

PEP delivery by EzPAP® device with manual chest physiotherapy .

Other: KP group

KM group

PLACEBO COMPARATOR

Manual chest physiotherapy only;

Other: KM group

Interventions

KP group OTHER

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

KP group

KM group OTHER

Also known as: Patients of the control group benefit only from manual chest physiotherapy twice a day

KM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes Universitary Hospital

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

FR (1)