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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: Fast Track Cardiac Anesthesia (FTCA); Procedure: Ultra Fast Track Cardiac Anesthesia (UFTCA)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trial office Trial Office; Phone Number: +39 0331449168; Email: trialoffice@asst-ovestmi.it

Study Locations

• Italy
  • Italy
    • Legnano, Italy, Italy, 20025
      • Recruiting
      • Trial Office
      • Contact: Trial office Trial office; Email: trialoffice@asst-ovestmi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fast track cardiac anesthesia (FTCA); Participants undergoing cardiac surgery via minithoracotomy receive a Fast Track Cardiac Anesthesia (FTCA) protocol.	Procedure: 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.
Active Comparator: Ultra Fast Track cardiac anesthesia (UFTCA); Participants undergoing cardiac surgery via minithoracotomy receive an Ultra Fast Track Cardiac Anesthesia (UFTCA) protocol, with the goal of tracheal extubation in the operating room immediately after completion of surgery, followed by postoperative monitoring and care according to standard institutional practice.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative pulmonary complications	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.	From ICU discharge to Day 7 post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and safety on postoperative recovery	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.	From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery	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.	From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery	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.	From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery	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.	From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery	Length of stay in the intensive care unit (ICU) and length of hospital stay. Unit of Measure: Days	From date of surgery until hospital discharge, up to 30 days
Efficacy and safety on postoperative recovery	Duration of endotracheal intubation. Unit of Measure: Hours	From endotracheal intubation to extubation, up to 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 13-2025; 5925 (Other Identifier: COMITATO ETICO TERRITORIALE LOMBARDIA 3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No