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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Anesthesia; Cardiac Disease
• Intervention / Treatment: Behavioral: Ultra Fast-track

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 Type: Interventional
• Enrollment (Estimated): 382
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lourdes Montero Cruces; Phone Number: 616622432; Email: lourdes.montero@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clínico San Carlos
    • Contact: Lourdes Montero Cruces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultra fast-track; Patients are extubated in the operating room after the procedure	Behavioral: Ultra Fast-track; Patients are extubated in the operating room
Active Comparator: Conventional extubation; Patients are extubated in the intensive unit care	Behavioral: Ultra Fast-track; Patients are extubated in the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of Ultra Fast-track	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Investigators: Principal Investigator: Lourdes Montero Cruces, Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 30, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 22/720-EC_X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No