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

NCT07518524 | Recruiting

• 2 other identifiers: 13-20255925
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Efficacy and safety on postoperative recovery

  From ICU discharge to Day 7 post-discharge

• Efficacy and safety on postoperative recovery

  From ICU discharge to Day 7 post-discharge

• Efficacy and safety on postoperative recovery

  From ICU discharge to Day 7 post-discharge

• Efficacy and safety on postoperative recovery

  From ICU discharge to Day 7 post-discharge

• Efficacy and safety on postoperative recovery

  From date of surgery until hospital discharge, up to 30 days

Study Arms (2)

Fast track cardiac anesthesia (FTCA)

ACTIVE COMPARATOR

Participants undergoing cardiac surgery via minithoracotomy receive a Fast Track Cardiac Anesthesia (FTCA) protocol.

Procedure: Fast Track Cardiac Anesthesia (FTCA)

Ultra Fast Track cardiac anesthesia (UFTCA)

ACTIVE COMPARATOR

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)

Interventions

Ultra Fast Track Cardiac Anesthesia (UFTCA) PROCEDURE

Tracheal extubation in the operating room immediately after completion of surgery, followed by postoperative monitoring and care according to standard institutional practice.

Ultra Fast Track cardiac anesthesia (UFTCA)

Fast Track Cardiac Anesthesia (FTCA) PROCEDURE

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.

Fast track cardiac anesthesia (FTCA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Trial Office

Legnano, Italy, 20025, Italy

RECRUITING

Central Study Contacts

Trial office Trial Office

CONTACT

+39 0331449168; trialoffice@asst-ovestmi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: April 8, 2026
• Study Start: June 18, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)