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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-22

Study Completion Date

2025-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

NCT01470976

Perioperative Hemodynamic Optimization Cardiac Surgery

COMPLETED PHASE3

Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients

NCT05285098

Post-cardiac Surgery

UNKNOWN

Ischemic Postconditioning in Cardiac Surgery

NCT01813968

Cardiac Surgery

COMPLETED NA

ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery

NCT02876406

Cardiac Surgery Disorder of Blood Gas Postoperative Complications +1 more

UNKNOWN

Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery

NCT03469440

Heart; Dysfunction Postoperative, Cardiac Surgery C.Surgical Procedure; Cardiac

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Disease Surgery Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Double

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultra fast-track

Patients are extubated in the operating room after the procedure

Group Type EXPERIMENTAL

Ultra Fast-track

Intervention Type BEHAVIORAL

Patients are extubated in the operating room

Conventional extubation

Patients are extubated in the intensive unit care

Group Type ACTIVE_COMPARATOR

Ultra Fast-track

Intervention Type BEHAVIORAL

Patients are extubated in the operating room

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultra Fast-track

Patients are extubated in the operating room

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No