Derivation and Validation of the Extended Care (Ex-Care) Model II (Ex-CareII)

Hospital de Clinicas de Porto Alegre

Status: Active, not recruiting

Conditions: Postoperative Complications

Study type: Observational

Funder types: Other

Identifiers

NCT05796024

2019.0192

Details and patient eligibility

About

The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is:

•Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery?

Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death).

The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.

Full description

From four predictors collected preoperatively ( American Society of Anesthesiology Physical Status (ASA-PS) classification, age, extent of surgery and its nature - elective vs urgency/emergency), through a multilevel logistic regression, a post-surgical in-hospital mortality prediction model will be developed, the Ex-Care II model. Discrimination and calibration measures will be used to determine the accuracy of the model. In addition, each predictor will have their odds ratio calculated for the study outcome. Once this model is developed, it will have its external validity tested in a second sample, using the same accuracy metrics.

Enrollment: 107,372 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study

Exclusion criteria

• Diagnostic procedures, with sedation only or with local anesthesia
• Patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation
• In the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement

Trial design

107,372 participants in 2 patient groups

Derivation Cohort

Description:

The derivation cohort will correspond to approximately 70% of the total sample to be analyzed in the study. The Ex-Care II risk model will build upon it. It is composed of patients operated in the participating institutions.

Validation Cohort

Description:

Composed of the remaining 30% of the sample. It will be used for the external validation of the Ex-Care II model