Postoperative Period
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All patients undergoing surgeries for cancer treatment performed between March and June 2019 and between March and June 2020, who underwent postoperative care in the intensive care unit; with a minimum age of 18 years; both genders
Exclusion criteria
Exclusion criteria: Advanced cancer with no prospective of treatment, severe hepatic failure (Child C); hospital stay less than 12 hours; patients who undergo reoperation before inclusion in the study; readmission to intensive care unit during the same hospital stay of study inclusion; previously included patients; pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1. It is expected to find an absolute increase from 9% to 25% in the cumulative incidence of death in 28 days in the group of patients operated during the pandemic compared to patients operated in the period before the pandemic. The outcome will be evaluated by analyzing data taken from the participants' electronic medical records. Due to the possibility of imbalances between the groups, adjusted analyzes were performed for the primary outcome using the Cox regression model;Outcome found 1. The proportional hazard ratio for 28-day cumulative mortality in the Cox regression model adjusted for urgent surgery, surgery time, Simplified Acute Physiology Score III, body mass index, sex, age, and institutions, between the 2019 and 2020 periods was 4 .35 (95% CI: 2.15-8.82) for patients from the 2020 period | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 5. Evaluate, through the analysis of data from the medical record, the length of stay in the intensive care unit;Outcome found 5. The median length of stay in the intensive care unit was 2.0 days (interquartile range 1.0-3.0) in 2019 and 2.0 days (interquartile range 1.0-3.0) in 2020 (p= 0.44 );Expected outcome 6. Evaluate, through the analysis of data from the medical records, the incidence of cardiovascular complications defined as: vasopressor administration for more than one hour, acute myocardial infarction, cardiac arrhythmias or cardiorespiratory arrest. Due to the possibility of imbalances between the groups, adjusted analysis was performed for the outcome using multiple logistic regression;Outcome found 6. Multivariate logistic regression model adjusted for Simplified Acute Physiology Score III and participating centers revealed an odds ratio of 0.99 (95% CI 0.83-1.17) for incidence of cardiovascular complications in the 2020 group in comparison to the 2019 group;Expected outcome 7. Evaluate, through the analysis of data from the medical record, the incidence of respiratory complications defined as: pneumonia, pulmonary embolism, positive test for COVID-19 or computed tomography image compatible with diagnosis of COVID-19, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation (defined as: any episode of non-invasive ventilation, invasive ventilation or extracorporeal membrane oxygenation after initial extubation after surgery or no extubation at the end of surgery as planned). Due to the possibility of imbalances between the groups, adjusted analysis was performed for the outcome using multiple logistic regression;Outcome found 7. Multivariate logistic regression model adjusted for Simplified Acute Physiology Score III and participating centers revealed an odds ratio of 5.35 (95% CI 1.42-20.21) for incidence of respiratory complications in the 2020 group compared to the 2019 group;Expected outcome 8. To evaluat | — |
Countries
Brazil
Contacts
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo