Mitral Regurgitation Clinical Trial
Official title:
Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery
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
Status | Not yet recruiting |
Enrollment | 204 |
Est. completion date | January 2019 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Raffaele | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of expiratory flow limitation in cardiac surgery | Immediately after weaning from cardiopulmonary bypass | ||
Primary | Incidence of Postoperative pulmonary complications in cardiac surgery | From immediately after cardiac surgery until discharge from the hospital | ||
Secondary | Duration of mechanical ventilation | Through study completion, an average of 24 hours after surgery | ||
Secondary | ICU length of stay | Through study completion, an average of 24 hours after surgery | ||
Secondary | Hospital length of stay | Through study completion, an average of 7 days after surgery | ||
Secondary | Re-admission to ICU | Through study completion, an average of 30 days after surgery | ||
Secondary | Need for reintubation | Through study completion, an average of 30 days after surgery | ||
Secondary | Need for non-invasive ventilation | Through study completion, an average of 30 days after surgery | ||
Secondary | Postoperative infections | Through study completion, an average of 30 days after surgery | ||
Secondary | Major adverse cardiac events | Through study completion, an average of 30 days after surgery | ||
Secondary | Incidence of mortality | Through study completion, 30 days and 1 year after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03278574 -
Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
|
N/A | |
Suspended |
NCT04960280 -
A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease
|
N/A | |
Recruiting |
NCT05021614 -
Valveclip® Transcatheter Mitral Valve Repair Study
|
N/A | |
Not yet recruiting |
NCT06465745 -
AltaValve Pivotal Trial
|
N/A | |
Not yet recruiting |
NCT06167213 -
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
|
N/A | |
Withdrawn |
NCT05040451 -
Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
|
||
Withdrawn |
NCT03714412 -
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
|
N/A | |
Recruiting |
NCT02592889 -
(MitraClip in Non-Responders to Cardiac Resynchronization Therapy)
|
Phase 4 | |
Completed |
NCT02355418 -
The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
|
||
Completed |
NCT01841554 -
Cardioband With Transfemoral Delivery System
|
N/A | |
Not yet recruiting |
NCT01431222 -
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
|
Phase 4 | |
Not yet recruiting |
NCT03870516 -
Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery
|
N/A | |
Active, not recruiting |
NCT03230747 -
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
|
N/A | |
Enrolling by invitation |
NCT04031274 -
Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
|
||
Completed |
NCT05836480 -
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
|
||
Completed |
NCT05850026 -
Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
|
||
Completed |
NCT05836532 -
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
|
||
Recruiting |
NCT03975998 -
Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
|
||
Completed |
NCT01162083 -
Identifying an Ideal Cardiopulmonary Exercise Test Parameter
|
N/A | |
Suspended |
NCT00787293 -
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
|
Phase 2 |