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Mechanical Ventilation During Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02090205
Recruitment Status : Unknown
Verified February 2016 by Elena Bignami, Ospedale San Raffaele.
Recruitment status was:  Recruiting
First Posted : March 18, 2014
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):
Elena Bignami, Ospedale San Raffaele

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Pneumothorax Atelectasis Aspiration Pneumonia Bronchospasm Procedure: Non-ventilation during CPB Procedure: Ventilation with CPAP Procedure: Ventilation with 5 act/minute Device: CPAP Device: Ventilator: 5 act/minute Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mechanical Ventilation During Cardiac Surgery, a Randomized Controlled Trial
Study Start Date : November 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Placebo Comparator: Non-ventilation during CPB
This group of patients will not be ventilated during the cardio-pulmonary bypass. They will be disconnected from the respirator.
Procedure: Non-ventilation during CPB
Patients that will not be ventilated during cardio-pulmonary bypass

Experimental: Ventilation with CPAP
This group will receive a ventilation with CPAP (at least 5 cmH2O) and FiO2 50%-80%
Procedure: Ventilation with CPAP
These patients will receive CPAP (at least 5 cmH2O and FiO2 50%-80%)

Device: CPAP
Continuous Positive Air Pressure, applicated during cardio-pulmonary bypass

Experimental: Ventilation with 5 act/minute
This group will receive 5 respiratory acts/minute. Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.
Procedure: Ventilation with 5 act/minute
These patients will receive mechanical ventilation (5 acts/minute) during CPB

Device: Ventilator: 5 act/minute
Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.

Primary Outcome Measures :
  1. Incidence of postoperative pulmonary complications [ Time Frame: Up to 1 year ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02090205

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Contact: Elena Bignami, MD 39.02.2643.4524

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P.O. Pineta Grande Recruiting
Castel Volturno, Caserta, Italy, 81030
Contact: Vincenzo Pota, MD   
Principal Investigator: Vincenzo Pota, MD         
Ospedale San Raffaele Recruiting
Milano, MI, Italy, 20132
Contact: Elena Bignami, MD    39.02.2643.4524   
Principal Investigator: Elena Bignami, MD         
IRCCS Monzino Not yet recruiting
Milan, MI, Italy, 20138
Contact: Erminio Sisillo, MD   
Principal Investigator: Erminio Sisillo, MD         
Spedali Civili Not yet recruiting
Brescia, Italy, 25128
Contact: Aldo Manzato, MD   
Principal Investigator: Aldo Manzato, MD         
Azienda Ospedaliera Brotzu Not yet recruiting
Cagliari, Italy, 09134
Contact: Romana Taccori, MD   
Principal Investigator: Romana Taccori, MD         
Ospedale San Martino Not yet recruiting
Genova, Italy, 16132
Contact: Patrizio Gastaldo, MD   
Contact: Paolo Pelosi, Full Prof   
Principal Investigator: Paolo Pelosi, Full Prof         
Sub-Investigator: Patrizio Gastaldo, MD         
Azienda Ospedaliero-Universitaria di Parma Recruiting
Parma, Italy, 43126
Contact: Alessandro M Budillon, MD   
Principal Investigator: Alessandro M Budillon, MD         
Azienda Ospedaliera di Perugia Recruiting
Perugia, Italy, 06156
Contact: Francesca Volpi, MD   
Principal Investigator: Francesca Volpi, MD         
Azienda Ospedaliera San Carlo Not yet recruiting
Potenza, Italy, 85100
Contact: Gianluca Paternoster, MD   
Principal Investigator: Gianluca Paternoster, MD         
Policlinico universitario Campus biomedico Recruiting
Roma, Italy, 00128
Contact: Claudia Grasselli, MD   
Principal Investigator: Claudia Grasselli, MD         
Policlinico Universitario Agostino Gemelli Not yet recruiting
Roma, Italy, 00168
Contact: Stefano De Paulis, MD;   
Sub-Investigator: Stefano De Paulis, MD         
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Sabino Scolletta, MD   
Principal Investigator: Sabino Scolletta, MD         
A.O.U. Santa Maria della misericordia Recruiting
Udine, Italy, 33100
Contact: Pierpaolo Accolla, MD   
Principal Investigator: Pierpaolo Accollo, MD         
Sponsors and Collaborators
Ospedale San Raffaele
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Principal Investigator: Elena Bignami, MD San Raffaele Hospital, Milan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Elena Bignami, MD, Ospedale San Raffaele Identifier: NCT02090205    
Other Study ID Numbers: CPBVENT2014
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Keywords provided by Elena Bignami, Ospedale San Raffaele:
cardio-pulmonary bypass
cardiac surgery
lung injury prevention
mechanical ventilation
pulmonary insufficiency
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Atelectasis
Bronchial Spasm
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Pleural Diseases
Bronchial Diseases