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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra fast-track | Experimental | Patients are extubated in the operating room after the procedure |
|
| Conventional extubation | Active Comparator | Patients are extubated in the intensive unit care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra Fast-track | Behavioral | Patients are extubated in the operating room |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural resources conpsumption | Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days). | 1 year |
| Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lourdes Montero Cruces | Hospital San Carlos, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico San Carlos | Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42046539 | Derived | Cruces LM, Alcazar MC, Sial RLB, Vizcayno ML, Martin RS, Camargo DP, Carnicer JC, Mercadal LA, Morenza AA, Lacruz FR, Fernandez PC, Molano MAG, Torron JMM, Chavez MBS, Castellanos LCM. Evaluation of clinical impact of ultra fast-track versus conventional extubation in patients undergoing nonemergency cardiac surgery: 'CARDU-FAST': A randomised clinical trial. Eur J Anaesthesiol. 2026 Apr 28. doi: 10.1097/EJA.0000000000002400. Online ahead of print. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)
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Double
Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.
| 1 year |
| Differences in major bleeding or life-threatening bleeding. | Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition). | 1 year |
| Differences in neurological complication | Comparison of the incidence of neurological complication after the procedure. | 1 year |
| Differences in the incidence of acute myocardial infarction. | Comparison of the incidence of acute myocardial infarction after the procedure. | 1 year |
| Differences in the incidence of heart reoperation | Comparison of the reoperation rate after the procedure. | 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. | 1 year |