Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Anesthesia; Cardiac Disease; Surgery
• Interventions: Behavioral: Ultra Fast-track

• Registration Number: NCT05706857
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.

Detailed Description

The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 382 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by December 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.

Study Timeline

• Study First Submitted: 2023-01-20
• Study Start: 2023-01-22
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-30
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

• Patients over 18 years of age.
• Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.
• The patient's desire to participate in the clinical trial verified by signing the informed consent.

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Exclusion Criteria

1. Pregnancy.
2. Emergent surgery or cardiorespiratory arrest.
3. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
4. Aortic arch procedures.
5. Procedures in which hypothermia < 28ºC of temperature is expected during the intervention.
6. Minor cardiac surgery procedures.
7. Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).
8. Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
9. Active endocarditis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultra fast-track	Ultra Fast-track	Patients are extubated in the operating room after the procedure
Conventional extubation	Ultra Fast-track	Patients are extubated in the intensive unit care

Primary Outcome Measures

Name	Time	Method
Determine the effect of Ultra Fast-track	1 year	Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.

Secondary Outcome Measures

Name	Time	Method
Differences in the incidence of heart reoperation	1 year	Comparison of the reoperation rate after the procedure.
Procedural resources conpsumption	1 year	Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.	1 year	Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for \>24h after the procedure.
Differences in the incidence of acute myocardial infarction.	1 year	Comparison of the incidence of acute myocardial infarction after the procedure.
Differences in major bleeding or life-threatening bleeding.	1 year	Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
Differences in the incidence of infections rate.	1 year	Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.
Differences in neurological complication	1 year	Comparison of the incidence of neurological complication after the procedure.

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain