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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Device: Manufacturer STELLAR 150

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control Group; Standard preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV	1 and 3 month

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Francis COUTURAUD, Pr, Département de Médecine Interne et de Pneumologie, CHU BREST

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2014
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimated): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac surgery; Preventive non-invasive ventilation
• Other Study ID Numbers: 29BRC13.0125