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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-27

Study Completion Date

2019-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery

NCT04884841

Surgery--Complications

RECRUITING

Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS

NCT02079454

Invos Peri-operative Cardiac Outcome

COMPLETED

Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

NCT03016182

Lung Injury Remote Ischemic Preconditioning

UNKNOWN NA

Stopping Cardiovascular Treatments and Mortality in a MICU

NCT04121429

Critical Care Medication Cardiovascular Diseases +1 more

UNKNOWN

Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery

NCT04251637

Thoracic Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Manufacturer STELLAR 150

Intervention Type DEVICE

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

Control Group

Standard preparation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No