Hospital Clínico San Carlos
Madrid, 28040, Spain
NCT Number: NCT05706857
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are extubated in the operating room
Time frame: 1 year
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
Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
Time frame: 1 year
Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.
Time frame: 1 year
Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
Time frame: 1 year
Comparison of the incidence of neurological complication after the procedure.
Time frame: 1 year
Comparison of the incidence of acute myocardial infarction after the procedure.
Time frame: 1 year
Comparison of the reoperation rate after the procedure.
Time frame: 1 year
Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.
Hospital San Carlos, Madrid
Other
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)
Acronym: CARDU-FAST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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