Postoperative Complications
Conditions
Keywords
risk assessement, validation study, postoperative, mortality
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Develop and validate a model for predicting the risk of in-hospital death within 30 days postoperatively, from a sample composed of patients operated in Brazil | Surgery day up to 30 days postoperatively | From four predictors collected preoperatively, the developed model will be able to estimate the probability of in-hospital death of patients undergoing surgery in Brazilian hospitals. For the creation of this tool, multilevel logistic regression will be made with hospital as a random effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Develop smartphone application contemplating the new model developed | Preoperative | In order to facilitate the use of the Ex-Care II model by health professionals involved in perioperative care, it will be created and made available on the main platforms for smartphones application that will allow the measurement of surgical risk by this new tool. |
Countries
Brazil
Outcome results
None listed