Incidence of PRAE on Asymptomatic and Symptomatic URI Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.
研究概览
简要总结
The objective of this study is to determine the prevalence of asymptomatic viral carriers among healthy surgical patients and to describe the demographic and clinical characteristics of these patients. The secondary objective is to compare the incidence of perioperative respiratory adverse events (PRAE) between virus positive patients with and without upper respiratory infection (URI) symptoms. The secondary objective would aim to enroll patients who report recent URI symptoms.
详细描述
The primary endpoint is to determine the prevalence of asymptomatic viral carriers among healthy pediatric surgical patients and describe the demographic and clinical characteristics of these patients. This will be done using prospectively collected respiratory swabs from healthy asymptomatic children undergoing elective pediatric surgery. This will result in a quantifiably proportion of children who test positive for respiratory viruses. This aim will define the epidemiologic baseline of silent viral URIs in children undergoing elective surgery. We can then evaluate the association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs). A secondary endpoint will be to compare the incidence of PRAE between virus positive patients with and without URI symptoms. This will be done by prospectively enrolling patients who report recent (within 2 weeks) or current URI symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients <18 years of age presenting for elective ambulatory procedures under general anesthesia at NCH. Patient will either identify as asymptomatic or have had URI symptoms currently or within the past two weeks.
排除标准
- •Chronic medical problems (excluding asthma), diagnosis of cancer, transplant recipient, receiving immunomodulatory medications (cyclosporine, tacrolimus, azathioprine, mycophenolate, monoclonal AB, lithium), or currently prescribed antibiotics.
研究组 & 干预措施
Healthy pediatric patients
Healthy pediatric patients without respiratory symptoms scheduled for surgery
干预措施: Mid-turbinate nasal swab (Diagnostic Test)
Recent URI patients
Pediatric patients who report recent (within two weeks) or current URI symptoms presenting for surgery
干预措施: Mid-turbinate nasal swab (Diagnostic Test)
结局指标
主要结局
Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.
时间窗: From enrollment to the end of the surgery, no more than 8 hours.
All patients will be tested for the presence of viruses that cause upper respiratory infections by taking a mid-turbinate nasal swab and using a PCR film array test.
次要结局
- Association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs).(Time of enrollment to time of hospital discharge, no more than 24 hours.)
研究者
Brittany Willer
Pediatric Anesthesiologist
Nationwide Children's Hospital