Ultra fast‑track versus fast‑track anesthesia after off‑pump and minimally invasive valve heart surgery
Official title: Studio Randomizzato Prospettico Comparativo di Due Protocolli di Gestione Perioperatoria Per Interventi di Cardiochirurgia Off Pump e di Chirurgia Valvolare Minitoracotomica
Run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano · NCT07518524 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano Academic / other |
| Locations | 1 site (Legnano, Italy) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | December 15, 2027 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT07518524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Trial Office
Legnano, Italy, Italy Recruiting
Study contacts
- Study coordinator: Trial office Trial Office
- Email: trialoffice@asst-ovestmi.it
- Phone: +39 0331449168
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.