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Completed

NCT Number: NCT02302300

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

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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manufacturer STELLAR 150

Device

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

Primary outcomes

  1. 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

  1. Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV

    Time frame: 1 and 3 month

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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.

Acronym: CAPVNI

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2014
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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