Registry of Anesthesia and Perioperative Medicine

NCT05869578 | Not Yet Recruiting

• 1 other identifier: UIEC1166
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

To assess mortality and morbidity associated to anesthesia interventions

Conditions

Perioperative Complication; Perioperative/Postoperative Complications; Anesthesia Morbidity; Anesthesia; Adverse Effect; Anesthesia Complication; Anesthesia; Reaction

Outcome Measures

Primary Outcomes (5)

• All-cause mortality rate in the postoperative period

  Posoperative mortality of individuals exposed to any anesthesia related intervention or event

  30 days

• All-cause mortality rate in the posoperative period

  Posoperative mortality of individuals exposed to any anesthesia related intervention or event

  one year

• Number of patients presenting a complication in the posoperative period

  Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.

  30 days

• Number of patients who needed rehospitalization in the posoperative period

  Posoperative rehospitalization rate of individuals exposed to any anesthesia related intervention or event, after primary discharge

  7 days after primary discharge

• Number of deaths in the postoperative period after readmission

  In-hospital mortality of patients that were readmitted after primary discharge

  up to 30 days

Secondary Outcomes (4)

• 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

• 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

• Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association

  7 and 30 days

• Number of patients that develop posoperative chronic pain as measured by visual analog scale

  3, 6, and 12 months

Interventions

Anesthesia Intervention PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• The subjects who had insufficient data in their files

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead

Study Sites (1)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7591538, Chile

Location

Related Publications (5)

• 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 BACKGROUND

• 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.

  PMID: 25127426 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 25085962 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Javiera A Vargas, MD

CONTACT

+56222101111; jvargasz@alemana.cl

Patricio A Leyton, MD

CONTACT

+5622101111; pleytonb@alemana.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2045
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

CL (1)