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

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ClinicalTrials.gov Identifier: NCT02633423
Recruitment Status : Not yet recruiting
First Posted : December 17, 2015
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Elena Bignami, Ospedale San Raffaele

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. 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

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Aortic Regurgitation Procedure: Use of PEEP before and after CPB Procedure: No use of PEEP before and after CPB(ZEEP) Procedure: Ventilation with CPAP during CPB Procedure: No ventilation during CPB Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery
Estimated Study Start Date : January 2, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: PEEP and CPAP
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
PEEP will be set in order to reach an airway pressure of 5 cmH2O

Procedure: Ventilation with CPAP during CPB
A continuous Positive Airway Pressure (CPAP) will be applied during CPB

Experimental: ZEEP and CPAP
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)
No PEEP will be used

Procedure: Ventilation with CPAP during CPB
A continuous Positive Airway Pressure (CPAP) will be applied during CPB

Experimental: PEEP and NO VM
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
PEEP will be set in order to reach an airway pressure of 5 cmH2O

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

Placebo Comparator: ZEEP and NO VM
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)
No PEEP will be used

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




Primary Outcome Measures :
  1. Incidence of expiratory flow limitation in cardiac surgery [ Time Frame: Immediately after weaning from cardiopulmonary bypass ]
  2. Incidence of Postoperative pulmonary complications in cardiac surgery [ Time Frame: From immediately after cardiac surgery until discharge from the hospital ]

Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: Through study completion, an average of 24 hours after surgery ]
  2. ICU length of stay [ Time Frame: Through study completion, an average of 24 hours after surgery ]
  3. Hospital length of stay [ Time Frame: Through study completion, an average of 7 days after surgery ]
  4. Re-admission to ICU [ Time Frame: Through study completion, an average of 30 days after surgery ]
  5. Need for reintubation [ Time Frame: Through study completion, an average of 30 days after surgery ]
  6. Need for non-invasive ventilation [ Time Frame: Through study completion, an average of 30 days after surgery ]
  7. Postoperative infections [ Time Frame: Through study completion, an average of 30 days after surgery ]
  8. Major adverse cardiac events [ Time Frame: Through study completion, an average of 30 days after surgery ]
  9. Incidence of mortality [ Time Frame: Through study completion, 30 days and 1 year after surgery ]


Information from the National Library of Medicine

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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
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT02633423


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

Locations
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Italy
Ospedale San Raffaele Not yet recruiting
Milano, MI, Italy, 20132
Contact: Elena Bignami, MD    39.02.2643.4524    bignami.elena@hsr.it   
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
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Principal Investigator: Elena Bignami, MD Ospedale San Raffaele

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elena Bignami, Professor, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT02633423     History of Changes
Other Study ID Numbers: EFLCCH
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Bignami, Ospedale San Raffaele:
Cardiopulmonary bypass
Mechanical ventilation
Expiratory Flow Limitation
Best PEEP
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases