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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02302300

Acronym

CAPVNI

Enrollment

216

Registered

2014-11-27

Start date

2014-05-27

Completion date

2019-02-26

Last updated

2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Cardiac surgery, Preventive non-invasive ventilation

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.

Interventions

DEVICEManufacturer STELLAR 150

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Appearance of cardio-pulmonary complications in postoperative cardiac surgery	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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026