Complexity and Frailty in Cardiothoracic and Vascular Anesthesia (CAfCA). Prospective Multicentric Observational Study

NCT05968456 | Recruiting

• 1 other identifier: CAfCA-3366
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Frailty; Anesthesia; Thoracic Surgery; Cardiothoracic Surgery; Vascular Surgery; Comorbidities and Coexisting Conditions

Keywords

Frailty; Thoracic surgery; Cardiac Surgery; Vascular Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• Frailty Prevalence comparison

  Frailty prevalence comparison among the three clinical areas: cardiac, thoracic, and vascular surgery

  at preoperative evaluation visit

Secondary Outcomes (11)

• Frailty assessment instruments comparison

  at preoperative evaluation visit

• Multimorbidity description

  at preoperative evaluation visit

• In-hospital complications

  up to 30 days after operation

• Unplanned ICU admission

  up to 30 days after operation

• Length of hospital stay

  up to 30 days after operation

Study Arms (3)

Thoracic surgery

Patient undergoing thoracic surgery

Other: Data collection

Cardiac surgery

Patient undergoing cardiac surgery

Other: Data collection

Vascular surgery

Patient undergoing vascular surgery

Other: Data collection

Interventions

Data collection OTHER

Observational study in patients undergoing thoracic, cardiac and vascular surgery.

Cardiac surgery; Thoracic surgery; Vascular surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients subjected to anesthesia for elective cardiac-thoracic-vascular surgery consecutively recruited during a period of 1 month designated by each partecipating center

You may qualify if:

• 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.

You may not qualify if:

• Patients subjected to surgery in urgency and emergency settings
• Procedures in one-day surgery settings
• Procedures without the involvement of anesthesiologists

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: collaborator

Study Sites (8)

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

COMPLETED

Spedali Civili di Brescia

Brescia, Italy

RECRUITING

ASST Ovest Milanese

Legnano, Italy

COMPLETED

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

COMPLETED

AOR San Carlo

Potenza, Italy

COMPLETED

Azienda Ospedaliero Universitaria Senese

Siena, Italy

COMPLETED

Azienda Ospedaliera Umberto I Mauriziano

Turin, Italy

RECRUITING

Città della salute e della Scienza di Torino

Turin, Italy

RECRUITING

Related Publications (17)

• Fowler AJ, Abbott TEF, Prowle J, Pearse RM. Age of patients undergoing surgery. Br J Surg. 2019 Jul;106(8):1012-1018. doi: 10.1002/bjs.11148. Epub 2019 May 22.

  PMID: 31115918 BACKGROUND

• Hamel MB, Henderson WG, Khuri SF, Daley J. Surgical outcomes for patients aged 80 and older: morbidity and mortality from major noncardiac surgery. J Am Geriatr Soc. 2005 Mar;53(3):424-9. doi: 10.1111/j.1532-5415.2005.53159.x.

  PMID: 15743284 BACKGROUND

• Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.

  PMID: 17116555 BACKGROUND

• Oresanya LB, Lyons WL, Finlayson E. Preoperative assessment of the older patient: a narrative review. JAMA. 2014 May;311(20):2110-20. doi: 10.1001/jama.2014.4573.

  PMID: 24867014 BACKGROUND

• McIsaac DI, MacDonald DB, Aucoin SD. Frailty for Perioperative Clinicians: A Narrative Review. Anesth Analg. 2020 Jun;130(6):1450-1460. doi: 10.1213/ANE.0000000000004602.

  PMID: 32384334 BACKGROUND

• Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

  PMID: 15031310 BACKGROUND

• Koh LY, Hwang NC. Frailty in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):521-531. doi: 10.1053/j.jvca.2018.02.032. Epub 2018 Feb 22. No abstract available.

  PMID: 29580797 BACKGROUND

• Gale CR, Cooper C, Sayer AA. Prevalence of frailty and disability: findings from the English Longitudinal Study of Ageing. Age Ageing. 2015 Jan;44(1):162-5. doi: 10.1093/ageing/afu148. Epub 2014 Oct 12.

  PMID: 25313241 BACKGROUND

• McIsaac DI, Wijeysundera DN, Huang A, Bryson GL, van Walraven C. Association of the Hospital Volume of Frail Surgical Patients Cared for with Outcomes after Elective, Major Noncardiac Surgery: A Retrospective Population-based Cohort Study. Anesthesiology. 2017 Apr;126(4):602-613. doi: 10.1097/ALN.0000000000001536.

  PMID: 28157134 BACKGROUND

• Lee JA, Yanagawa B, An KR, Arora RC, Verma S, Friedrich JO; Canadian Cardiovascular Surgery Meta-Analysis Working Group. Frailty and pre-frailty in cardiac surgery: a systematic review and meta-analysis of 66,448 patients. J Cardiothorac Surg. 2021 Jun 25;16(1):184. doi: 10.1186/s13019-021-01541-8.

  PMID: 34172059 BACKGROUND

• Sivaharan A, Boylan L, Witham MD, Nandhra S; Northern Vascular Centre. Sarcopenia in Patients Undergoing Lower Limb Bypass Surgery is Associated with Higher Mortality and Major Amputation Rates. Ann Vasc Surg. 2021 Aug;75:227-236. doi: 10.1016/j.avsg.2021.02.022. Epub 2021 Apr 2.

  PMID: 33819585 BACKGROUND

• Tsiouris A, Hammoud ZT, Velanovich V, Hodari A, Borgi J, Rubinfeld I. A modified frailty index to assess morbidity and mortality after lobectomy. J Surg Res. 2013 Jul;183(1):40-6. doi: 10.1016/j.jss.2012.11.059. Epub 2012 Dec 21.

  PMID: 23273884 BACKGROUND

• Beckert AK, Huisingh-Scheetz M, Thompson K, Celauro AD, Williams J, Pachwicewicz P, Ferguson MK. Screening for Frailty in Thoracic Surgical Patients. Ann Thorac Surg. 2017 Mar;103(3):956-961. doi: 10.1016/j.athoracsur.2016.08.078. Epub 2016 Oct 6.

  PMID: 27720368 BACKGROUND

• Handforth C, Clegg A, Young C, Simpkins S, Seymour MT, Selby PJ, Young J. The prevalence and outcomes of frailty in older cancer patients: a systematic review. Ann Oncol. 2015 Jun;26(6):1091-1101. doi: 10.1093/annonc/mdu540. Epub 2014 Nov 17.

  PMID: 25403592 BACKGROUND

• Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr. 2016 Aug 31;16(1):157. doi: 10.1186/s12877-016-0329-8.

  PMID: 27580947 BACKGROUND

• Stortecky S, Schoenenberger AW, Moser A, Kalesan B, Juni P, Carrel T, Bischoff S, Schoenenberger CM, Stuck AE, Windecker S, Wenaweser P. Evaluation of multidimensional geriatric assessment as a predictor of mortality and cardiovascular events after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2012 May;5(5):489-496. doi: 10.1016/j.jcin.2012.02.012.

  PMID: 22625186 BACKGROUND

• Velanovich V, Antoine H, Swartz A, Peters D, Rubinfeld I. Accumulating deficits model of frailty and postoperative mortality and morbidity: its application to a national database. J Surg Res. 2013 Jul;183(1):104-10. doi: 10.1016/j.jss.2013.01.021. Epub 2013 Feb 1.

  PMID: 23415494 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Federico Piccioni, Dr

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Piccioni, Dr

CONTACT

0282244151; federico.piccioni@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesia Section 1

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: October 10, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

IT (8)