Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.
The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 612 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
612
Patients are extubated in the operating room
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Determine the effect of Ultra Fast-track
Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.
Time frame: 1 year
Procedural resources conpsumption
Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
Time frame: 1 year
Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.
Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for \>24h after the procedure.
Time frame: 1 year
Differences in major bleeding or life-threatening bleeding.
Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
Time frame: 1 year
Differences in neurological complication
Comparison of the incidence of neurological complication after the procedure.
Time frame: 1 year
Differences in the incidence of acute myocardial infarction.
Comparison of the incidence of acute myocardial infarction after the procedure.
Time frame: 1 year
Differences in the incidence of heart reoperation
Comparison of the reoperation rate after the procedure.
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Time frame: 1 year
Differences in the incidence of infections rate.
Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.
Time frame: 1 year