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

NCT02633423 | Unknown DMC

• 1 other identifier: EFLCCH
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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

Conditions

Mitral Regurgitation; Aortic Regurgitation

Keywords

Cardiopulmonary bypass; Mechanical ventilation; Expiratory Flow Limitation; Best PEEP

Outcome Measures

Primary Outcomes (2)

• Incidence of expiratory flow limitation in cardiac surgery

  Immediately after weaning from cardiopulmonary bypass

• Incidence of Postoperative pulmonary complications in cardiac surgery

  From immediately after cardiac surgery until discharge from the hospital

Secondary Outcomes (9)

• Duration of mechanical ventilation

  Through study completion, an average of 24 hours after surgery

• ICU length of stay

  Through study completion, an average of 24 hours after surgery

• Hospital length of stay

  Through study completion, an average of 7 days after surgery

• Re-admission to ICU

  Through study completion, an average of 30 days after surgery

• Need for reintubation

  Through study completion, an average of 30 days after surgery

Study Arms (4)

PEEP and CPAP

EXPERIMENTAL

Patients will be ventilated with positive end-expiratory pressure(PEEP) before and after cardiopulmonary bypass(CPB); during CPB continous positive airway pressure(CPAP) will be adopted.

Procedure: Use of PEEP before and after CPB; Procedure: Ventilation with CPAP during CPB

ZEEP and CPAP

EXPERIMENTAL

Patients will be ventilated without PEEP(ZEEP) before and after cardiopulmonary bypass(CPB); during CPB continous positive airway pressure(CPAP) will be adopted.

Procedure: No use of PEEP before and after CPB(ZEEP); Procedure: Ventilation with CPAP during CPB

PEEP and NO VM

EXPERIMENTAL

Patients will be ventilated with positive end-expiratory pressure(PEEP) before and after cardiopulmonary bypass(CPB); during CPB no mechanical ventilation will be adopted(no VM)

Procedure: Use of PEEP before and after CPB; Procedure: No ventilation during CPB

ZEEP and NO VM

PLACEBO COMPARATOR

Patients will be ventilated without PEEP(ZEEP) before and after cardiopulmonary bypass(CPB); during CPB no mechanical ventilation will be adopted(no VM)

Procedure: No use of PEEP before and after CPB(ZEEP); Procedure: No ventilation during CPB

Interventions

Use of PEEP before and after CPB PROCEDURE

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

PEEP and CPAP; PEEP and NO VM

No use of PEEP before and after CPB(ZEEP) PROCEDURE

No PEEP will be used

ZEEP and CPAP; ZEEP and NO VM

Ventilation with CPAP during CPB PROCEDURE

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

PEEP and CPAP; ZEEP and CPAP

No ventilation during CPB PROCEDURE

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

PEEP and NO VM; ZEEP and NO VM

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective cardiac surgery, with median sternotomy and two-lungs ventilation;
• Patients scheduled for mitral valve regurgitation and/or aortic valve regurgitation surgery, performed with CPB and aortic cross-clamping;
• Adult patients (age 18 or higher);
• Ability to provide informed consent.
• High risk for respiratory dysfunction, defined as 1 of: preoperative hypoxemia (arterial oxygen saturation \< 92% in room air or arterial oxygen partial pressure \< 60 mmHg at blood gas analysis or a PaO2/FiO2 ratio \< 200 at basal blood gas analysis); preoperative obesity (BMI \> 30); preoperative ejection fraction \< 50%; preoperative NYHA class \> II; age \> 65 years.

You may not qualify if:

• Non-elective cardiac surgery;
• Anticipated circulatory arrest, TAVI, Mitraclip;
• Patient's refusal;
• Pregnancy;
• Thoracotomic approach, with one lung ventilation;
• Previous pulmonary resection;
• Patients with acute kidney injury requiring dialysis;
• Patients with chronic kidney insufficiency (stage III or greater);
• Patients already intubated before arrival in operating theatre;
• Pneumonia in the previous 30 days.

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (1)

• Bignami E, Spadaro S, Saglietti F, Di Lullo A, Corte FD, Guarnieri M, de Simone G, Giambuzzi I, Zangrillo A, Volta CA. Positive end-expiratory pressure (PEEP) level to prevent expiratory flow limitation during cardiac surgery: study protocol for a randomized clinical trial (EFLcore study). Trials. 2018 Nov 26;19(1):654. doi: 10.1186/s13063-018-3046-0.

  PMID: 30477541 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency; Aortic Valve Insufficiency

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Elena Bignami, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Bignami, MD

CONTACT

39.02.2643.4524; bignami.elena@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 17, 2015
• Study Start: January 2, 2018
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

IT (1)