Clinical trial NCT02302300: Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac surgery
Preventive non-invasive ventilation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Appearance of cardio-pulmonary complications in postoperative cardiac surgery
timeFrame: 1 month
Secondary outcomes:
measure: Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV
timeFrame: 1 and 3 month
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
affiliation: Département de Médecine Interne et de Pneumologie, CHU BREST
name: Francis COUTURAUD, Pr
role: PRINCIPAL_INVESTIGATOR
References: