Ultra fast‑track versus fast‑track anesthesia after off‑pump and minimally invasive valve heart surgery
Studio Randomizzato Prospettico Comparativo di Due Protocolli di Gestione Perioperatoria Per Interventi di Cardiochirurgia Off Pump e di Chirurgia Valvolare Minitoracotomica
This will test whether an ultra fast‑track anesthesia approach helps adults having elective off‑pump or minimally invasive valve heart surgery get extubated sooner and leave the ICU and hospital earlier than standard fast‑track anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano Academic / other |
| Locations | 1 site (Legnano, Italy) |
| Trial ID | NCT07518524 on ClinicalTrials.gov |
What this trial studies
This interventional protocol compares two anesthesia pathways—fast‑track cardiac anesthesia (FTCA) and ultra fast‑track cardiac anesthesia (UFTCA)—in adults undergoing elective off‑pump cardiac or minimally invasive valve surgery via minithoracotomy. Patients who consent and meet inclusion criteria are treated according to one of the protocols with the goal of early tracheal extubation in the operating room or shortly after surgery. Key outcomes include time to extubation, intensive care unit and hospital length of stay, and perioperative safety events such as respiratory or hemodynamic complications. Patients with significant respiratory failure, major hemodynamic instability, prolonged cardiopulmonary bypass, active bleeding, or other clinical contraindications are excluded.
Who should consider this trial
Good fit: Adults (over 18) scheduled for elective off‑pump cardiac surgery or minimally invasive valve surgery via minithoracotomy who can provide informed consent are the intended participants.
Not a fit: Patients with respiratory failure (P/F ratio <200), hemodynamic instability requiring more than one vasoactive drug, prolonged cardiopulmonary bypass, active perioperative bleeding, core temperature <35°C, pregnancy, or those not extubated within 6 hours postoperatively are unlikely to benefit from the ultra fast‑track approach.
Why it matters
Potential benefit: If successful, the ultra fast‑track approach could shorten mechanical ventilation time and reduce ICU and hospital length of stay, lowering costs and speeding recovery.
How similar studies have performed: Previous fast‑track anesthesia studies have shown earlier extubation can reduce ICU and hospital length of stay, while ultra fast‑track protocols are less extensively studied but have shown promising results in select cardiac populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Legnano, Italy
- Trial Office — Legnano, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Trial office Trial Office
- Email: trialoffice@asst-ovestmi.it
- Phone: +39 0331449168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.