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

Cardiac Surgery Clinical Trial

— CAPVNI  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02302300
• Other study ID #: RB 13.125 CAPVNI
• Status: Recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Brest
• Contact: Marion GORET, Physiotherapist
• Phone: +00 332 98 34 74 30
• Email: marion.goret[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
France	CHU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appearance of cardio-pulmonary complications in postoperative cardiac surgery	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	1 month
Secondary	Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV		1 and 3 month