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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Cardiac Surgery

Treatments

Device: Manufacturer STELLAR 150

Study type

Interventional

Funder types

Other

Identifiers

NCT02302300
29BRC13.0125

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

216 participants in 2 patient groups

Manufacturer STELLAR 150
Experimental group
Description:
5 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative.
Treatment:
Device: Manufacturer STELLAR 150
Control Group
No Intervention group
Description:
Standard preparation

Trial contacts and locations

1

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Central trial contact

Marion GORET, Physiotherapist

Data sourced from clinicaltrials.gov

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