Registry of Anesthesia and Perioperative Medicine

Official title

Registry of Patients Subjected to the Perioperative Care of the Anesthesia Service of Clinica Alemana of Santiago Chile

Overview

To assess mortality and morbidity associated to anesthesia interventions

Detailed description

Currently evidence-based medicine is one of the most important tools guiding our medical practice. Part of this evidence has been generated from clinical records, which has allowed access to large databases from which relevant information has been obtained for perioperative risk stratification, searching for complications, having specific information on procedures, among others.

A clear example, especially useful daily in anesthesia work, is the NSQIP score, a tool that allows calculating perioperative risk according to the conditions of the patient and the surgery. NSQIP score is considered to make decisions in both the American and the European guidelines for preoperative evaluation for surgery.

Latin-American or Chilean databases are not available at the present time. Chile lacks of population perioperative databases, methodology and practice of medicine outcomes records, thus making necessary the generation of a retrospective/prospective registry.

The investigators expect that this registry will allow the collection of perioperative information appropriate to characterize the Chilean population, observe its evolution, and detect risk factors. Moreover, this registry will grant the investigators the means to design new research studies that may allow them to gather medical evidence of superior quality, thus benefiting patients with the best and safest interventions and procedures.

Interventions

• Procedure Anesthesia Intervention
  Patients exposed to any anesthesia intervention will be assessed to whether the exposure to anesthesia confers a risk for perioperative outcomes

Primary outcome measures

• All-cause mortality rate in the postoperative period [Time frame: 30 days]
• All-cause mortality rate in the posoperative period [Time frame: one year]
• Number of patients presenting a complication in the posoperative period [Time frame: 30 days]
• Number of patients who needed rehospitalization in the posoperative period [Time frame: 7 days after primary discharge]
• Number of deaths in the postoperative period after readmission [Time frame: up to 30 days]

Secondary outcome measures (4)

• Change from baseline in pain, as measured by the visual analog scale (VAS) [Time frame: Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS]
• Number of patients that develops postoperative acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KIDGO)-2012 serum creatinine criteria [Time frame: 7 and 30 days]
• Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association [Time frame: 7 and 30 days]
• Number of patients that develop posoperative chronic pain as measured by visual analog scale [Time frame: 3, 6, and 12 months]

Eligibility criteria

Inclusion criteria

• All individuals
• Individuals agreeing to participate in the study by signing a consent

Exclusion criteria

• The subjects who had insufficient data in their files

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Chile · 1 center

• Clinica Alemana de Santiago — Santiago

Publications

• Abdel-Kader AK, Eisenkraft JB, Katz DJ. Overview and Limitations of Database Research in Anesthesiology: A Narrative Review. Anesth Analg. 2021 Apr 1;132(4):1012-1022. doi: 10.1213/ANE.0000000000005346. PMID 33346984
• Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, De Hert S, Ford I, Gonzalez Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luescher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Uva MS, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Join PMID 25127426
• Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5. PMID 21730309
• Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Card PMID 25085962
• Bosco E, Hsueh L, McConeghy KW, Gravenstein S, Saade E. Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review. BMC Med Res Methodol. 2021 Nov 6;21(1):241. doi: 10.1186/s12874-021-01440-5. PMID 34742250

Identifiers

NCT: NCT05869578 · UIEC1166

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗