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Clinical Trials/NCT02302300
NCT02302300
Completed
Not Applicable

Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery, in Disease Prevention of the Cardiac and/or Lung Complications at the Patients at Risk.

University Hospital, Brest1 site in 1 country216 target enrollmentMay 27, 2014
ConditionsCardiac Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
University Hospital, Brest
Enrollment
216
Locations
1
Primary Endpoint
Appearance of cardio-pulmonary complications in postoperative cardiac surgery
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 27, 2014
End Date
February 26, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Every patient of more than 18 years, programmed for a cardiac surgery ( valve replacement, coronary bypass, aortic surgery) in the service of "Chirurgie Cardio-Thoracique et Vasculaire" (CCTV) of the CHRU of Brest
  • and obesity (BMI \> 30 kg/m2
  • and/or COPD (stages 1-2 and 3, classification GOLD)
  • and/or restrictive syndrome (CPT 80 %)
  • and/or cardiac insufficiency (FEVG 55 %)
  • and/or syndrome of obesity-hypoventilation not requiring an equipment
  • and/or Syndrome of sleep apnea not requiring an equipment

Exclusion Criteria

  • Patients having a contraindication absolved from the NIV
  • Patients carrier of a neuro-muscular disease
  • Patients carrier of a syndrome of sleep apnea and/or COPD, and sailed
  • Hypercapnic patients (with a limit value of PaCO2 \> 55 mm Hg)
  • Unaffiliated patients to a social diet of safety
  • Patients under guardianship or under guardianship
  • Patient who can not follow the NIV program as well as the patients of whom the consent was not collected.

Outcomes

Primary Outcomes

Appearance of cardio-pulmonary complications in postoperative cardiac surgery

Time Frame: 1 month

Appearance of cardio-pulmonary complications in postoperative cardiac surgery among the complications listed below: * Atelectasis * Acute respiratory insufficiency * Acute cardiac insufficiency * Pneumothorax * Arrhythmia * Myocardial infarction * Cardiac tamponade

Secondary Outcomes

  • Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV(1 and 3 month)

Study Sites (1)

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