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临床试验/NCT05133648
NCT05133648进行中(未招募)不适用

Association of Anesthesia Technique With Morbidity and Mortality in Patients With COVID-19 and Surgery for Hip Fracture: a Retrospective Population Cohort Study

University of British Columbia1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

Patients with COVID undergoing hip fracture repair have high mortality rates. If spinal anesthesia is associated with decreased rates of mortality, this study could provide hypothesis generating data for prospective studies. Investigators hypothesize that spinal anesthesia (SA) is associated with decreased mortality compared to general anesthesia (GA) for patients undergoing hip fracture surgery. The primary objective is to determine for patients undergoing hip surgery with COVID-19 infection, whether SA, as compared to GA, is associated with a lower rate of mortality 30 days postoperatively. The secondary objective is to determine whether SA, as compared to GA, is associated with a lower rate of morbidity 30 days postoperatively. Investigators will be analyzing a data set provided by the National Surgical Quality Improvement Program (NSQIP). Descriptive statistics will be performed. Multivariable logistic regression will be performed for the primary and secondary objectives.

详细描述

Background: Patients with hip fracture have poor outcomes, attributed to risk factors that include advanced age and higher rates of underlying chronic comorbidities. COVID-19 infection is an independent risk factor for increased mortality in hip fracture patients in the perioperative period. A recent meta-analysis demonstrates COVID-19 infection is associated with higher than seven-fold increase in risk of mortality. Recommended management of hip fracture includes timely surgical repair, multimodal pain control, and multidisciplinary follow-up, to facilitate return to mobility and independent function.

Anesthesia for hip fracture surgery can be achieved by either general anesthesia (GA) or spinal anesthesia (SA). The potential advantages of SA include opioid-sparing effects, lessened impacts on the respiratory and gastrointestinal systems, and reduction in rates of adverse outcomes such as pneumonia, mechanical ventilation, intensive care unit (ICU) admission, venous thromboembolism (VTE), myocardial infarction (MI), stroke, transfusion, readmission, and prolonged postoperative length of stay. However, a recent randomized control trial found no difference between SA and GA for older adults undergoing hip fracture surgery for the primary outcome of survival and recovery of ambulation at 60 days.

While emerging evidence shows COVID-19 infection increases mortality after hip surgery, there is a lack of research examining whether the choice of anesthetic technique modifies the postoperative mortality and morbidity of hip fracture patients with COVID-19 infection. This is particularly important due to the high mortality (35% in COVID-positive patients, vs. 2% in patients without COVID), with the potential for SA to modify this risk by circumventing the need for airway interventions. SA may also offer superiority over general anesthesia for limiting aerosol generation and exposure of operating room staff during the pandemic. While SA may reduce the risk of pulmonary morbidity by reducing the need for airway interventions, its motor block on accessory muscles and the need for sedation may adversely impact ventilation. Investigators hypothesize that spinal anesthesia (SA) is associated with decreased mortality compared to general anesthesia (GA) for patients undergoing hip fracture surgery.

Study Design: The requirement for written informed consent will be waived for use of deidentified data. Patient information will be obtained for the retrospective cohort analysis using the NSQIP® (general dataset linked with the Hip Fracture Procedure Targeted Dataset), a prospectively-collected multicentre dataset with more than 150 clinical variables within 30 days after surgery. The setting of this study will be patient data obtained from the multicentre generated NSQIP Hip Fracture Procedure Targeted Dataset. The period of patient data obtained will include from January 2017 through December 2021. We will omit the data from January 2020 to December 2020 given there was no reporting of COVID status during this period. Data will only be obtained from patients undergoing hip surgery with mortality and morbidity gathered for 30 days postoperatively. In this study, the investigators goal is to evaluate the adjusted association between anesthesia technique and mortality and morbidity after hip fracture surgery for patients who tested positive for COVID-19.

The primary objective is to determine for patients undergoing hip surgery with COVID-19 infection, whether SA, as compared to GA, is associated with a lower rate of mortality 30 days postoperatively.

研究设计

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

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sampled in the NSQIP Hip Fracture Procedure Targeted Dataset from January 2017 through December 2019 and from January 2021 to December
  • undergoing surgical fixation of hip fractures using either general and/or spinal anesthesia.
  • In case of reduced Procedure-Targeted data collection during the COVID-19 pandemic, investigators will also create a total open hip fracture cohort using relevant Current Procedural Terminology codes (27244, 27245, 27269, 27236, or 27248)

排除标准

  • Primary or secondary anesthetic technique listed as local anesthesia alone, local anesthesia with intravenous sedation, epidural, and those with no reported anesthesia technique
  • American Society of Anesthesiologists (ASA) Physical Status (PS) V (defined as "5-Moribund"), and
  • Ventilator-dependence preoperatively.
  • Platelet counts less than 80,000/mm3 within 90 days before surgery,
  • International normalized ratio (INR) greater than or equal to 1.5, or
  • Partial thromboplastin time (PTT) greater than 35 seconds (likelihood of being ineligible for SA)

结局指标

主要结局

All-cause mortality

时间窗: 30 days post operatively

All-cause 30-day mortality following hip fracture surgery.

次要结局

  • Pneumonia(Within 30 days post operatively)
  • Postoperative Delirium(Within 30 days post operatively)
  • Hospital Stay greater than 30 days(Greater than 30 days postoperatively)
  • Discharge Destination(Postoperative Period at Time of discharge, on average 5 days)
  • Any Complication or Death(Within 30 days post operatively)
  • Transfusion(Within 30 days post operatively)
  • Stroke or cerebrovascular accident (CVA)(Within 30 days post operatively)
  • Myocardial Infarction (MI)(Within 30 days post operatively)
  • Acute Renal Failure(Within 30 days post operatively)
  • Post-Operative Ventilation(Within 30 days post operatively)
  • Hospital Readmission(Within 30 days post operatively)
  • Unplanned Reoperation(Within 30 days post operatively)
  • Venous Thromboembolism(Within 30 days post operatively)
  • Length of Stay(Post-operative period in hospital, on average 5 days)
  • Sepsis(Within 30 days post operatively)

研究者

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

Janny Ke

Clinical Assistant Professor

University of British Columbia

研究点 (1)

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