Mechanical Ventilation During Cardiac Surgery

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.

Conditions

• Respiratory Failure
• Pneumothorax
• Atelectasis
• Aspiration Pneumonia
• Bronchospasm

Interventions

PROCEDURE

Non-ventilation during CPB

Patients that will not be ventilated during cardio-pulmonary bypass

PROCEDURE

Ventilation with CPAP

These patients will receive CPAP (at least 5 cmH2O and FiO2 50%-80%)

PROCEDURE

Ventilation with 5 act/minute

These patients will receive mechanical ventilation (5 acts/minute) during CPB

DEVICE

CPAP

Continuous Positive Air Pressure, applicated during cardio-pulmonary bypass

DEVICE

Ventilator: 5 act/minute

Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.

Sponsors & Collaborators

• Ospedale San Raffaele

  lead OTHER

Principal Investigators

• Elena Bignami, MD · San Raffaele Hospital, Milan

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2016-12-31

Completion

2017-06-30

Countries

• Italy

Study Locations