Trial Office
Legnano, Italy, 20025
Location status: Recruiting
NCT Number: NCT07518524
Fast-track cardiac anesthesia (FTCA) has gained significant popularity over the past decades due to its potential to reduce healthcare costs and optimize the use of medical resources. This approach has led anesthesiologists to reconsider the traditional model of cardiac anesthesia, known as Conventional Cardiac Anesthesia (CCA), which historically relied on the administration of high-dose opioids to ensure adequate hemodynamic stability and prolonged postoperative analgesia, thereby reducing the incidence of myocardial ischemia.
One of the primary goals of fast-track cardiac anesthesia is early tracheal extubation. Increasing evidence demonstrates that early extubation is associated with a reduction in the length of stay in the intensive care unit (ICU) and overall hospital length of stay, resulting in significant cost savings without negatively affecting patients' clinical outcomes. In contrast, prolonged mechanical ventilation has been shown to have a substantial economic impact and, more importantly, is associated with higher in-hospital mortality and reduced long-term survival, including decreased five-year survival rates. The Ultra Fast Track protocol, which involves extubation directly in the operating room, is currently less commonly used. However, it may further reduce postoperative mechanical ventilation time and the incidence of pulmonary complications, potentially leading to an additional reduction in hospital length of stay. The aim of this study is to compare the Fast Track and Ultra Fast Track protocols in order to evaluate differences in the incidence of respiratory, cardiac, renal, septic, and neurological complications. Postoperative pain will also be assessed using the Numeric Rating Scale (NRS), as well as the incidence of postoperative nausea and vomiting (PONV).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Legnano, Italy, 20025
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Balanced general anesthesia with early extubation within 6 hours after surgery, followed by standard postoperative monitoring and care in the intensive care unit according to institutional practice.
Tracheal extubation in the operating room immediately after completion of surgery, followed by postoperative monitoring and care according to standard institutional practice.
Time frame: From ICU discharge to Day 7 post-discharge
Incidence of postoperative pulmonary complications (PPCs), defined as a composite outcome including pneumonia, pleural effusion, atelectasis, or pneumothorax, within 7 days after ICU discharge or before hospital discharge (whichever occurs first), according to European Perioperative Clinical Outcome (EPCO) definitions.
Unit of Measure: Percentage of participants with at least one PPC.
Time frame: From ICU discharge to Day 7 post-discharge
Incidence of postoperative delirium assessed using the Confusion Assessment Method for the ICU (CAM-ICU) on postoperative day 0 and day 1.
Unit of Measure: Percentage of events in the observation window.
Time frame: From ICU discharge to Day 7 post-discharge
Incidence of cardiovascular complications, defined as a composite outcome including heart failure, myocardial ischemia, atrial fibrillation, or renal failure.
Unit of Measure: Percentage of events in the observation window.
Time frame: From ICU discharge to Day 7 post-discharge
Incidence of neurological complications, defined as a composite outcome including transient ischemic attack (TIA) or stroke.
Unit of Measure: Percentage of events in the observation window.
Time frame: From ICU discharge to Day 7 post-discharge
Incidence of septic complications, defined as a composite outcome including infection, sepsis, or septic shock.
Unit of Measure: Percentage of events in the observation window.
Time frame: From date of surgery until hospital discharge, up to 30 days
Length of stay in the intensive care unit (ICU) and length of hospital stay. Unit of Measure: Days
Time frame: From endotracheal intubation to extubation, up to 48 hours postoperatively
Duration of endotracheal intubation. Unit of Measure: Hours
Contact information is provided by the study sponsor or research team.
Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
Other
Studio Randomizzato Prospettico Comparativo di Due Protocolli di Gestione Perioperatoria Per Interventi di Cardiochirurgia Off Pump e di Chirurgia Valvolare Minitoracotomica
Acronym: Fast Track
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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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