MedTrace Logo

Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery

NCT02633423 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2017-12-06

No results posted yet for this study

Summary

During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed. The reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the FRC and leads to a phenomenon called expiratory flow limitation (EFL). Positive End-Expiratory Pressure (PEEP) test is a validated method to evaluate the presence of EFL during anesthesia. Aim of the study will be to asses if mechanical ventilation during CardioPulmonary Bypass (CPB) in cardiac surgery could reduce the incidence of EFL in the post-CPB period. Primary end-point will be the incidence of EFL, assessed by a PEEP test, performed at different time-points in operating room. Co-primary end-point will be shunt fraction, determined before and after surgery.

This will be a single center single-blind parallel group randomized controlled trial. Patients will be randomly assigned to four parallel arms with an allocation ratio 1:1:1:1, to receive one of four mechanical ventilation strategies during CPB.

1. Ventilation with a Positive End-Expiratory Pressure (PEEP) of 5 cmH2O before and after CPB; Continuous Positive Airway Pressure (CPAP) during CPB;
2. Ventilation without PEEP before and after CPB; CPAP during CPB;
3. Ventilation with a PEEP of 5 cmH2O before and after CPB; No use of mechanical ventilation during CPB
4. Ventilation without PEEP before and after CPB; No use of mechanical ventilation during CPB

Conditions

  • Mitral Regurgitation
  • Aortic Regurgitation

Interventions

PROCEDURE

Use of PEEP before and after CPB

PEEP will be set in order to reach an airway pressure of 5 cmH2O

PROCEDURE

No use of PEEP before and after CPB(ZEEP)

No PEEP will be used

PROCEDURE

Ventilation with CPAP during CPB

A continuous Positive Airway Pressure (CPAP) will be applied during CPB

PROCEDURE

No ventilation during CPB

No ventilation will be provided during CPB. Patients will be deconnected from ventilator. Lungs will completely collapse.

Sponsors & Collaborators

  • Ospedale San Raffaele

    lead OTHER

Principal Investigators

  • Elena Bignami, MD · Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2018-07-31
Completion
2019-01-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633423 on ClinicalTrials.gov