Registry of Anesthesia and Perioperative Medicine

Not yet recruiting

• Conditions: Perioperative/Postoperative Complications; Anesthesia; Adverse Effect; Perioperative Complication; Anesthesia Morbidity; Anesthesia Complication; Anesthesia; Reaction

• Registration Number: NCT05869578
• Lead Sponsor: Clinica Alemana de Santiago

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.

Study Timeline

• Study First Submitted: 2023-04-27
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Study Start: 2023-06-01
• Primary Completion: 2035-01-01
• Study Completion: 2045-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality rate in the postoperative period	30 days	Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Number of patients who needed rehospitalization in the posoperative period	7 days after primary discharge	Posoperative rehospitalization rate of individuals exposed to any anesthesia related intervention or event, after primary discharge
All-cause mortality rate in the posoperative period	one year	Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Number of patients presenting a complication in the posoperative period	30 days	Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.
Number of deaths in the postoperative period after readmission	up to 30 days	In-hospital mortality of patients that were readmitted after primary discharge

Secondary Outcome Measures

Name	Time	Method
Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association	7 and 30 days	Criteria for MACE are the development of any of the following conditions Non-fatal stroke Non-fatal myocardial infarction Cardiovascular death
Change from baseline in pain, as measured by the visual analog scale (VAS)	Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS	Scores are measured on a 10-point VAS. The VAS ranges from 0 to 10 with 0 indicating no pain, and higher scores indicating greater pain.
Number of patients that develops postoperative acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KIDGO)-2012 serum creatinine criteria	7 and 30 days	Criteria for developing acute kidney injury are: Increase in serum creatinin by ≽0.3 mg/dl (≽26.5lmol/l) within 48hours; or Increase in serum creatinine ≽1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume \< 0.5ml/kg/h for 6hours.
Number of patients that develop posoperative chronic pain as measured by visual analog scale	3, 6, and 12 months	Scores are measured on a 10-point VAS. The VAS ranges from 0 to 10 with 0 indicating no pain, and higher scores indicating greater pain.

Trial Locations

Locations (1)

Clinica Alemana de Santiago; 🇨🇱 Santiago, Region Metropolitana De Santiago, Chile