Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery (CARDU-FAST)

San Carlos Clinical Hospital

Status: Completed

Conditions: Cardiac Disease; Surgery; Anesthesia

Treatments: Behavioral: Ultra Fast-track

Study type: Interventional

Funder types: Other

Identifiers

NCT05706857

22/720-EC_X

Details and patient eligibility

About

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.

Full 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 612 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 September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.

Enrollment: 612 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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612 participants in 2 patient groups

Ultra fast-track

Experimental group

Description:

Patients are extubated in the operating room after the procedure

Treatment:

Behavioral: Ultra Fast-track

Conventional extubation

Active Comparator group

Description:

Patients are extubated in the intensive unit care

Treatment:

Behavioral: Ultra Fast-track