Respiratory Failure Clinical Trial
Official title:
Mechanical Ventilation During Cardiac Surgery, a Randomized Controlled Trial
Background There is no unanimous opinion about a lung-protective strategy in cardiac
surgery. Small randomized clinical and animals trials suggest that ventilation during
cardio-pulmonary bypass (CPB) could be protective on the lungs. This evidence is based on
surrogate end-points and most of studies are limited to elective coronary surgery. According
to the available data, an optimal strategy of lung protection during CPB cannot be
recommended. The purpose of the CPBVENT study is to investigate the effectiveness of
different ventilation strategies during CPB on post-operative pulmonary complications.
Trial design The CPBVENT study will be a single-blind, multicenter, randomized controlled
trial. We are going to enroll 780 patients undergoing elective cardiac surgery with planned
use of CPB, aortic cross-clamping and two lung ventilation. Patients will be randomized into
three treatment groups: 1) no ventilation during CPB; 2) continuous positive airway pressure
(CPAP) with positive end-expiratory pressure (PEEP) of 5 cmH2O during CPB; 3) ventilation
with 5 acts/minute with tidal volume of 2-3 ml/Kg and a PEEP of 3-5 cmH2O during CPB. The
primary end-point will be the incidence of a PaO2/FiO2 ratio <200 until the time of
discharge from the ICU. The secondary end-points will be the incidence of post-operative
pulmonary complications and 30-days mortality. Patients will be followed-up to 12 months
after the date of randomization.
Summary The CPBVENT Trial will determine whether different ventilation strategies during CPB
will improve pulmonary outcome in patients undergoing cardiac surgery.
Status | Recruiting |
Enrollment | 780 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Age > 18 years old - Ability to provide an informed consent - Elective surgery - Surgical intervention with cardio-pulmonary bypass, aortic clamp and cardioplegia - Cardiac valvular surgery, coronary artery surgery, ascending aortic surgery and/or combined - Planned cardiac surgery with median sternotomy and bi-pulmonary ventilation Exclusion Criteria: - Patient refusal to provide informed consent - Emergency surgery - Patients with previous cardiac surgery - Cardiac surgery with planned circulatory arrest or aortic endoprosthesis or TAVI/MitraClip - Planned thoracotomy with one lung ventilation - Patients with BMI >30 - Patients with chronic kidney insufficiency (defined as dialysis) - Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive pulmonary disease, obstructive apnea syndrome) - Patients already intubated in the peri-operative period - Patients with pneumonia in the pre-operative period (30 days before surgery) - Patients with previous thoracic surgery (pulmonary resection) - Patients with: oxygen saturation < 90% and/or oxygen arterial pressure < 60 mmHg and/or P/F ratio <300 and/or carbon dioxide pressure > 45 mmHg - Patients with levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels increased >= 2 folds above the upper limit. - Patients with ejection fraction < 40% - Patients with pulmonary hypertension (defined as PAPm > 30mmHg) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Spedali Civili | Brescia | |
Italy | Azienda Ospedaliera Brotzu | Cagliari | |
Italy | P.O. Pineta Grande | Castel Volturno | Caserta |
Italy | Ospedale San Martino | Genova | |
Italy | IRCCS Monzino | Milan | MI |
Italy | Ospedale San Raffaele | Milano | MI |
Italy | Azienda Ospedaliero-Universitaria di Parma | Parma | |
Italy | Azienda Ospedaliera di Perugia | Perugia | |
Italy | Azienda Ospedaliera San Carlo | Potenza | |
Italy | Policlinico Universitario Agostino Gemelli | Roma | |
Italy | Policlinico universitario Campus biomedico | Roma | |
Italy | Azienda Ospedaliera Universitaria Senese | Siena | |
Italy | A.O.U. Santa Maria della misericordia | Udine |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of postoperative pulmonary complications | We aim to assess the number of incidence (defined as percentage of all events) of post-operative pulmonary complications up to 1 year after the surgical intervention. Our goal is to reduce this number with the ventilation during cardio-pulmonary bypass. | Up to 1 year | No |
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