Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197282
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2024-01-05
Brief Title:
Impact of COVID-19 on Surgical Outcomes
Sponsor:
Kern Medical Center
Organization:
Kern Medical Center
Study Overview
Official Title:
Impact of COVID-19 on Surgical Outcomes in Acute Care Service in a Community Hospital
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
SARS-CoV-2 COVID-19 has infected over 100000000 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 hospitals 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 7696 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 institutions 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
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 hospitals 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 7696 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 institutions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None