Retrospective Evaluation of Patients With Coronavirus 19 Infection Undergoing Major Orthopedic Urgent Surgery: a Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 mortality
研究概览
简要总结
Over the last months, the Rizzoli Orthopedic Institute in Bologna, Italy, has drained orthopedic urgencies from all other hospitals in the urban and suburban area. In this context urgencies are defined as fractures and primary or metastatic bone lesions with indication to non-deferrable surgery. A subset of these patients tested positive for SARS CoV 2, either before or after the surgical procedure.
Anesthesiological clinical management of covid19 cases is complicated by the consequences of the viral infection on respiratory and cardio-vascular systems, renal function and coagulation. Similarly, management of asymptomatic patients is challenging because of the lack of data on possible specific complications.
This study will report a snapshot of our early experience on perioperative clinical management of patients undergoing orthopedic surgery in the presence of SARS CoV 2 infection, ascertained or not at the time of surgery.
详细描述
This is a monocentric, retrospective, observational study.
the study will analyze all medical records of patients that underwent major or non-delayable orthopaedic surgery from the 1st of March 2020 to the 30th of June 2020 with known ongoing Coronavirus infection or postoperative diagnosis via nasal swab test collected at Rizzoli Orthopaedic Institute.
Medical history, anthropometrical, clinical, radiological, and biochemical data will be inserted in a database.
Primary objective will be to estimate population mortality in the time frame from surgery to hospital discharge.
Secondary objectives will be estimation of correlation between SARS-CoV2 infection and main postoperative complications. Mortality and site infection rate will be compared among the cohort and pre-COVID19 similar data.
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
- 否
入选标准
- •Patients urdergoing non-deferrable Orthopaedical surgery
- •Ascertained SARS-CoV-2 infection detected by nasopharyngeal swab before of after the surgery
- •Written, signed informed consent to the trial.
排除标准
- •Lack of signed informed consent.
结局指标
主要结局
SARS-CoV-2 mortality
时间窗: at baseline (day 0)
Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery
SARS-CoV-2 infection
时间窗: at baseline (day 0)
Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery
次要结局
- Known SARS-CoV2 infection(at baseline (day 0))
- SARS-CoV2 infection and DVT/PE(at baseline (day 0))
- SARS-CoV2 infection and TEG(at baseline (day 0))
- Surgical site infection in SARS-CoV2 patients vs historical population(at baseline (day 0))
- Known SARS-CoV2 infection and type of anesthesia(at baseline (day 0))
- Mortality in SARS-CoV2 patients vs historical population(at baseline (day 0))
- Population(at baseline (day 0))
- SARS-CoV2 and surgical site infection(at baseline (day 0))
- Known SARS-CoV2 mortality(at baseline (day 0))
- SARS-CoV2 and postoperative oxygen therapy(at baseline (day 0))