Anesthesia Clinical Trial
— CAfCAOfficial title:
Complexity and Frailty in Cardiothoracic and Vascular Anesthesia (CAfCA). Prospective Multicentric Observational Study
NCT number | NCT05968456 |
Other study ID # | CAfCA-3366 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 10, 2023 |
Est. completion date | April 30, 2024 |
Frailty is a multidimensional syndrome characterized by a decline in physiological homeostatic reserve, which translates into an increased susceptibility to adverse events and unfavorable outcomes following even small exposures to physical, physiological or psychosocial stress. In the European population up to 69 years, the prevalence is generally 6,5%, beyond 85 years of age it exceeds 50% and reaches 65% in the over-ninety population. The prevalence of frailty in the surgical population varies, depending on the studies, from 10 to 40%. Frailty and its severity grade represent themselves noticeably as strong predictors of adverse postoperative outcomes. The strongest evidence of association is recorded between frailty and mortality at 30 days. The purpose of this study is to describe the characteristics of patients undergoing anesthesia for cardiothoracic and vascular surgery, with a specific focus on frailty elements and associated comorbidities that necessitate surgery. This data analysis will provide valuable insights into the interaction between frailty, multimorbidity, and the perioperative pathway of patients undergoing cardiothoracic and vascular anesthesia.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | April 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients scheduled for elective cardiac, thoracic or vascular surgery - Patients aged 18 or older - Patients who have provided informed consent to participate in the study. Exclusion Criteria: - Patients subjected to surgery in urgency and emergency settings - Procedures in one-day surgery settings - Procedures without the involvement of anesthesiologists |
Country | Name | City | State |
---|---|---|---|
Italy | Spedali Civili di Brescia | Brescia | |
Italy | ASST Ovest Milanese | Legnano | |
Italy | Fondazione IRCCS Policlinico S. Matteo | Pavia | |
Italy | AOR San Carlo | Potenza | |
Italy | Istituto Clinico Humanitas | Rozzano | Lombardia |
Italy | Azienda Ospedaliero Universitaria Senese | Siena | |
Italy | Azienda Ospedaliera Umberto I Mauriziano | Turin | |
Italy | Città della salute e della Scienza di Torino | Turin |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas | Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva |
Italy,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frailty Prevalence | Determine the prevalence of frailty in the sample using the Clinical Frailty Score, in the three clinical areas: cardiac, thoracic, and vascular surgery | at preoperative evaluation visit | |
Primary | Frailty Prevalence comparison | Frailty prevalence comparison among the three clinical areas: cardiac, thoracic, and vascular surgery | at preoperative evaluation visit | |
Secondary | Frailty assessment instruments comparison | Agreement between different frailty instruments | at preoperative evaluation visit | |
Secondary | Multimorbidity description | Describe the multimorbidity profile of the included patients. | at preoperative evaluation visit | |
Secondary | In-hospital complications | Incidence of in-hospital complications | up to 30 days after operation | |
Secondary | Unplanned ICU admission | Unplanned ICU admissions rate | up to 30 days after operation | |
Secondary | Length of hospital stay | Length of hospital stay (days) | up to 30 days after operation | |
Secondary | In-hospital mortality | In-hospital mortality rate | up to 30 days after operation | |
Secondary | 30-day mortality | Mortality rate at 30 days after intervention | up to 30 days after operation | |
Secondary | Association between different frailty risk scores and clinical outcomes | Association between different frailty risk scores and clinical outcomes (complications, length of stay, mortality) | up to 30 days after operation | |
Secondary | Correlation between perioperative risk scores and frailty scores | Correlation between perioperative risk scores and frailty scores | at preoperative evaluation visit | |
Secondary | Description of the perioperative clinical pathway | Describe the perioperative clinical care pathway followed by the enrolled subjects | up to 30 days after operation | |
Secondary | Description of the anesthesiologic techniques adopted | Provide details on the anesthesiologic techniques utilized and the level of invasiveness of hemodynamic monitoring employed. | up to 30 days after operation |
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