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Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery

NCT02302300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-02-06

No results posted yet for this study

Summary

After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.

Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.

Conditions

  • Cardiac Surgery

Interventions

DEVICE

Manufacturer STELLAR 150

5 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Francis COUTURAUD, Pr · Département de Médecine Interne et de Pneumologie, CHU BREST

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-27
Primary Completion
2019-02-26
Completion
2019-02-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302300 on ClinicalTrials.gov