Cardiac SurgeryFast TrackNCT07518524
Ultra Fast-Track vs Fast-Track Protocols in Off-Pump and Minimally Invasive Valve Cardiac Surgery
A study testing Fast Track Cardiac Anesthesia (FTCA) and Ultra Fast Track Cardiac Anesthesia (UFTCA) in people with Cardiac Surgery, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Fast Track Cardiac Anesthesia (FTCA) and Ultra Fast Track Cardiac Anesthesia (UFTCA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2025to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Trial Office
Legnano, Italy, 20025
Trial office Trial office, trialoffice@asst-ovestmi.it
About this study
Official title: 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).
- Conditions
- Cardiac Surgery
- Being tested
- Fast Track Cardiac Anesthesia (FTCA), Ultra Fast Track Cardiac Anesthesia (UFTCA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Track Cardiac Anesthesia (FTCA)Procedure or surgery
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.
Ultra Fast Track Cardiac Anesthesia (UFTCA)Procedure or surgery
Tracheal extubation in the operating room immediately after completion of surgery, followed by postoperative monitoring and care according to standard institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| Fast track cardiac anesthesia (FTCA) | Active comparator | Participants undergoing cardiac surgery via minithoracotomy receive a Fast Track Cardiac Anesthesia (FTCA) protocol. Receives: 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. Receives: Procedure: Ultra Fast Track Cardiac Anesthesia (UFTCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU discharge to Day 7 post-discharge
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From endotracheal intubation to extubation, up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start18 Jun 2025
- Primary completion1 Mar 2026
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518524
- Sponsor's protocol ID
- 13-2025
- Other IDs
- 5925
- Acronym
- Fast Track
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Randomizzato Prospettico Comparativo di Due Protocolli di Gestione Perioperatoria Per Interventi di Cardiochirurgia Off Pump e di Chirurgia Valvolare Minitoracotomica
- ClinicalTrials.gov ID
- NCT07518524
- Acronym / sponsor ID
- Fast Track / 13-2025
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di LegnanoUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast track cardiac anesthesia (FTCA) | Active comparator | Procedure: Fast Track Cardiac Anesthesia (FTCA)Participants undergoing cardiac surgery via minithoracotomy receive a Fast Track Cardiac Anesthesia (FTCA) protocol. |
| Ultra Fast Track cardiac anesthesia (UFTCA) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Fast track cardiac anesthesia (FTCA) |
| 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. | Procedure or surgery | Ultra Fast Track cardiac anesthesia (UFTCA) |
Primary outcome
Incidence of postoperative pulmonary complications
Time frame: From ICU discharge to Day 7 post-discharge
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.
6 secondary outcomes
Efficacy and safety on postoperative recovery
Time frame: From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery
Time frame: From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery
Time frame: From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery
Time frame: From ICU discharge to Day 7 post-discharge
Efficacy and safety on postoperative recovery
Time frame: From date of surgery until hospital discharge, up to 30 days
Efficacy and safety on postoperative recovery
Time frame: From endotracheal intubation to extubation, up to 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Track Cardiac Anesthesia (FTCA) and Ultra Fast Track Cardiac Anesthesia (UFTCA) in people with Cardiac Surgery, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial office Trial Office (+39 0331449168, trialoffice@asst-ovestmi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary complications (time frame: From ICU discharge to Day 7 post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.