Mechanical Ventilation During Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Ospedale San Raffaele
Sponsor:
Information provided by (Responsible Party):
Elena Bignami, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT02090205
First received: March 8, 2014
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Mechanical Ventilation During Cardiac Surgery, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ospedale San Raffaele:

Primary Outcome Measures:
  • Incidence of postoperative pulmonary complications [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 780
Study Start Date: November 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090205

Contacts
Contact: Elena Bignami, MD 39.02.2643.4524 bignami.elena@hsr.it

Locations
Italy
IRCCS Monzino Not yet recruiting
Milan, MI, Italy, 20138
Contact: Paola Moliterni, MD    02580021    paolamoliterni@libero.it   
Principal Investigator: Paola Moliterni, MD         
Ospedale San Raffaele Recruiting
Milano, MI, Italy, 20132
Contact: Elena Bignami, MD    39.02.2643.4524    bignami.elena@hsr.it   
Principal Investigator: Elena Bignami, MD         
Azienda Ospedaliero-Universitaria di Parma Recruiting
Parma, Italy, 43126
Contact: Alessandro M Budillon, MD       ambudillon@ao.pr.it   
Principal Investigator: Alessandro M Budillon, MD         
Azienda Ospedaliera di Perugia Not yet recruiting
Perugia, Italy, 06156
Contact: Francesca Volpi, MD       francescavolpi80@gmail.com   
Principal Investigator: Francesca Volpi, MD         
Azienda Ospedaliera San Carlo Not yet recruiting
Potenza, Italy, 85100
Contact: Gianluca Paternoster, MD       paternostergianluca@gmail.com   
Principal Investigator: Gianluca Paternoster, MD         
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Sabino Scolletta, MD       sabino.scolletta@unisi.it   
Principal Investigator: Sabino Scolletta, MD         
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
Principal Investigator: Elena Bignami, MD San Raffaele Hospital, Milan
  More Information

No publications provided

Responsible Party: Elena Bignami, MD, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT02090205     History of Changes
Other Study ID Numbers: CPBVENT2014
Study First Received: March 8, 2014
Last Updated: March 23, 2015
Health Authority: Italy: Ministry of Health

Keywords provided by Ospedale San Raffaele:
cardio-pulmonary bypass
cardiac surgery
lung injury prevention
mechanical ventilation
pulmonary insufficiency

Additional relevant MeSH terms:
Pneumonia, Aspiration
Bronchial Spasm
Pneumothorax
Respiratory Insufficiency
Bronchial Diseases
Lung Diseases
Pleural Diseases
Pneumonia
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2015