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临床试验/NCT06197282
NCT06197282已完成不适用

Impact of COVID-19 on Surgical Outcomes in Acute Care Service in a Community Hospital

Kern Medical Center1 个研究点 分布在 1 个国家目标入组 7,696 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,696
试验地点
1
主要终点
Surgical complication rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Surgical complication rate

时间窗: 05/05/2020-12/01/2022

Post operative morbidity and mortality rate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amber Jones

Principal Investigator, DO, MPH

Kern Medical Center

研究点 (1)

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