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

Plain English Summary

Ultra Fast-Track vs Fast-Track Protocols in Off-Pump and Minimally Invasive Valve Cardiac Surgery is a Not Applicable clinical trial sponsored by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano studying Cardiac Surgery. This study compares two methods of anesthesia management after heart surgery: Fast-Track and Ultra Fast-Track. It is for adult patients undergoing specific types of elective heart surgery. Participation involves being randomly assigned to one of the two anesthesia protocols and following standard post-surgery care. Alternatives include standard anesthesia protocols that may involve longer breathing tube use. The trial aims to enroll 50 participants.

Official 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).

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults over 18 years old scheduled for elective off-pump heart surgery or minimally invasive valve surgery. Patients must be able to provide consent. Cannot join if extubated more than 6 hours after surgery, pregnant, or have certain immediate post-surgery complications like severe breathing issues or instability. This trial is studying Cardiac Surgery, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if one anesthesia method leads to fewer breathing problems after surgery compared to the other. The specific primary outcome measures are: Incidence of postoperative pulmonary complications (From ICU discharge to Day 7 post-discharge). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to find the best anesthesia approach to speed up recovery and reduce complications after certain heart surgeries, potentially improving patient outcomes and resource use. This research targets Cardiac Surgery, where improved treatment options are needed.

Investor Insight

This study focuses on optimizing post-cardiac surgery recovery protocols, a critical area for improving patient care and hospital efficiency in a significant surgical market.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of both Fast-Track and Ultra Fast-Track anesthesia for your surgery. Participation means you will be randomly assigned to one of the two anesthesia groups. You will receive standard post-operative care, with the main difference being how quickly the breathing tube is removed. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 50 participants

Interventions

• 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.
• 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.

Primary Outcomes

• Incidence of postoperative pulmonary complications (From ICU discharge to Day 7 post-discharge)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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.

Trial Locations

• Trial Office, Legnano, Italy, Italy

Frequently Asked Questions

Related Conditions

• Cardiac Surgery
• Heart Valve Surgery
• Minimally Invasive Surgery
• Anesthesia
• Postoperative Care
• Intensive Care Unit (ICU)
• Mechanical Ventilation
• Pulmonary Complications
• Cardiac Anesthesia
• Perioperative Management

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