Clinical trial NCT05869578: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perioperative Complication
Perioperative/Postoperative Complications
Anesthesia Morbidity
Anesthesia; Adverse Effect
Anesthesia Complication
Anesthesia; Reaction
Lead sponsor: Clinica Alemana de Santiago
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals of all ages being admitted at Clinica Alemana de Santiago that will require or were in care by an anesthesiologist.

Brief summary: 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.

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

Primary outcomes:
measure: All-cause mortality rate in the postoperative period
timeFrame: 30 days
measure: All-cause mortality rate in the posoperative period
timeFrame: one year
measure: Number of patients presenting a complication in the posoperative period
timeFrame: 30 days
measure: Number of patients who needed rehospitalization in the posoperative period
timeFrame: 7 days after primary discharge
measure: Number of deaths in the postoperative period after readmission
timeFrame: up to 30 days
Secondary outcomes:
measure: Change from baseline in pain, as measured by the visual analog scale (VAS)
timeFrame: Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS
measure: Number of patients that develops postoperative acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KIDGO)-2012 serum creatinine criteria
timeFrame: 7 and 30 days
measure: Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association
timeFrame: 7 and 30 days
measure: Number of patients that develop posoperative chronic pain as measured by visual analog scale
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana De Santiago
Study officials:
References:
citation: 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.
citation: 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 Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol. 2014 Oct;31(10):517-73. doi: 10.1097/EJA.0000000000000150. No abstract available.
citation: 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.
citation: 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 Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):2215-45. doi: 10.1161/CIR.0000000000000105. Epub 2014 Aug 1. No abstract available.
citation: 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.