Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06197282 |
| Other study ID # |
22152 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2020 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
January 2024 |
| Source |
Kern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Following the introduction of the COVID-19 vaccination, elective surgeries have resumed,
allowing for greater insight into the postoperative period and outcomes aims on-going
COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity and
mortality in patients who had surgery within one year of testing positive for COVID-19.
Description:
SARS-CoV-2 (COVID-19) has infected over 100,000,000 million people in the United States (US).
During the "first wave" in the US, medical facilities were advised to limit operative
exposure, stratify operative cases by both risk and urgency and cancel elective procedures.
With over 60% of the US population considered fully vaccinated as of May of 2020, elective
surgeries resumed amid periodic outbreaks allowing for continued insight into the impact of
COVID-19 on the postoperative recovery process. However, relative to the volume of data on
active infections, there is far less concerning the sequelae of previous infections.
Therefore, the purpose of this study is to analyze a safety net hospital's experience
regarding postoperative complications in patients that underwent surgical procedures
requiring general anesthesia within a year of testing positive for COVID-19.
This is a retrospective study from a high-volume tertiary referral center and safety net
hospital in Bakersfield, California. After approval by the Institutional Review Board, the
electronic health record (EHR) was queried for all positive COVID-19 patients that underwent
a surgical procedure of any kind requiring general anesthesia from 5 May 2020 to 31 December
2022. A total of 7,696 patients met inclusion criteria. 420 tested positive for COVID-19.
Participants were subdivided into three study groups defined as symptomatic COVID-19
infection, asymptomatic COVID-19 infection, and COVID-19 negative control group.
Individual chart review allowed for subclassification based on symptomatology, admission
status, length of admission, American Society of Anesthesiologist Physical Status
Classification System (ASA), qSOFA and GCS rating along with COVID-19 and surgical
complications Patients were required to have a COVID-19 diagnosis within one year of surgery.
Categorical variables assessed in participants included age, sex, BMI, race, ICU or DOU stay.
Post-operative complications assessed for included hospital length of stay, 30-day mortality,
30-day readmission, cardiac arrest, septic shock, acute kidney injury, acute respiratory
distress syndrome, deep vein, thrombosis, pulmonary embolism, respiratory failure and
pneumonia.
Statistical analysis was completed by the institution's statistician. Using Fisher extract,
ANOVA, univariate and multivariate logistic regression analyses, odds ratios and p-values
were obtained to evaluate for statistically significant correlations between categorical
variables.
