Clinical trial NCT06197282: Impact of COVID-19 on Surgical Outcomes
Official title: Impact of COVID-19 on Surgical Outcomes in Acute Care Service in a Community Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Surgical Outcomes
Postoperative Complications
Keywords: Postoperative outcomes
COVID-19
Lead sponsor: Kern Medical Center
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 7696
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who presented to Kern Medical Center, a high-volume tertiary referral center and safety net hospital located in Bakersfield, California between May 2020 to December 2022, who underwent a surgical procedure requiring general anesthesia. Participants were required to have a EHR documented SAR-CoV-2 PCR nasopharyngeal swab within one preoperatively.

Study excludes surgical procedures using only MAC or local anesthesia as well as percutaneous endoscopic gastrostomy tube placement.

A total of 7,696 patients were included, 420 tested positive for COVID-19 (7.6% were symptomatic and 4.8% were asymptomatic) and 7,276 tested negative (10.9% qualified as control).

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 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.

Eligibility criteria: Inclusion Criteria:

* Documented SAR-CoV-2 PCR nasopharyngeal swab within 1 year of major surgical intervention requiring general anesthesia

Exclusion Criteria:

* Surgical procedures using solely MAC and/or local anesthesia. Additionally, percutaneous endoscopic gastrostomy tube placements were omitted.

Primary outcomes:
measure: Surgical complication rate
timeFrame: 05/05/2020-12/01/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Medical Center
state: California
Study officials:
References: