Ultra Fast-Track vs Fast-Track Protocols in Off-Pump and Minimally Invasive Valve Cardiac Surgery

Официальное название

Studio Randomizzato Prospettico Comparativo di Due Protocolli di Gestione Perioperatoria Per Interventi di Cardiochirurgia Off Pump e di Chirurgia Valvolare Minitoracotomica

Обзор

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).

Вмешательства

• Процедура Fast Track Cardiac Anesthesia (FTCA)
  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.
• Процедура Ultra Fast Track Cardiac Anesthesia (UFTCA)
  Tracheal extubation in the operating room immediately after completion of surgery, followed by postoperative monitoring and care according to standard institutional practice.

Первичные конечные точки

• Incidence of postoperative pulmonary complications [Срок оценки: From ICU discharge to Day 7 post-discharge]

Вторичные конечные точки (6)

• Efficacy and safety on postoperative recovery [Срок оценки: From ICU discharge to Day 7 post-discharge]
• Efficacy and safety on postoperative recovery [Срок оценки: From ICU discharge to Day 7 post-discharge]
• Efficacy and safety on postoperative recovery [Срок оценки: From ICU discharge to Day 7 post-discharge]
• Efficacy and safety on postoperative recovery [Срок оценки: From ICU discharge to Day 7 post-discharge]
• Efficacy and safety on postoperative recovery [Срок оценки: From date of surgery until hospital discharge, up to 30 days]
• Efficacy and safety on postoperative recovery [Срок оценки: From endotracheal intubation to extubation, up to 48 hours postoperatively]

Критерии участия

Критерии включения

• Patients over 18 years of age
• All patients scheduled for elective off-pump cardiac surgery or minimally invasive valve surgery via minithoracotomy, who provide explicit consent to participate in the protocol and sign the informed consent form.

Критерии исключения

• Patients extubated more than 6 hours postoperatively
• Positive pregnancy test
• Patients who, for clinical reasons, cannot be awakened in the operating room, including difficult intubation, respiratory failure with P/F ratio < 200, hemodynamic instability requiring more than one vasoactive drug, cardiopulmonary bypass duration > 150 minutes, active perioperative bleeding, core temperature < 35°C.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Trial Office — Legnano

Идентификаторы

NCT: NCT07518524 · 13-2025 · 5925

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗