NCT02302300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

4.8 years

First QC Date

July 29, 2014

Last Update Submit

February 4, 2025

Conditions

Cardiac Surgery

Keywords

Cardiac surgeryPreventive non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 and 3 month

Study Arms (2)

Manufacturer STELLAR 150

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Standard preparation

Interventions

Manufacturer STELLAR 150DEVICE

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

Manufacturer STELLAR 150

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brest

Brest, 29200, France

Location

Related Publications (1)

  • Goret M, Pluchon K, Le Mao R, Badra A, Oilleau JF, Morvan Y, Beaumont M, Desanglois G, Guegan M, Barnier A, Gut-Gobert C, Tromeur C, Leroyer C, Choplain JN, Khalifa A, Bezon E, Couturaud F. Impact of Noninvasive Ventilation Before and After Cardiac Surgery for Preventing Cardiac and Pulmonary Complications: A Clinical Randomized Trial. Chest. 2025 Jun;167(6):1727-1736. doi: 10.1016/j.chest.2025.02.010. Epub 2025 Feb 19.

    PMID: 39984118DERIVED

Study Officials

  • Francis COUTURAUD, Pr

    Département de Médecine Interne et de Pneumologie, CHU BREST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

November 27, 2014

Study Start

May 27, 2014

Primary Completion

February 26, 2019

Study Completion

February 26, 2019

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

FR(1)