A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Time to Definitive Diagnosis
研究概览
简要总结
The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology.
详细描述
This study is a randomized, prospective interventional study of pregnant patients presenting to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This study will be conducted at 4 sites across the United States. Patients who are eligible and consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound that is performed by a certified emergency department attending or physician, or 2) a pelvic ultrasound that is performed by a certified radiology technician (standard-of-care). The time to diagnosis and emergency department length of stay between the two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •have a positive serum or urine beta-human chorionic gonadotropin (hCG)
- •estimated gestational age (EGA) of less than 20 weeks
- •complaint of pelvic pain and/or vaginal bleeding
排除标准
- •prior known documentation of an intrauterine pregnancy
- •estimated gestational age (EGA) of greater than 20 weeks
- •peritoneal findings on physical examination
- •unstable vital signs as deemed appropriate by the attending physician
- •prisoners
- •open cervix upon physical examination
研究组 & 干预措施
Emergency Medicine Physician Ultrasound
Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
干预措施: Emergency Medicine Physician Ultrasound (Other)
Emergency Medicine Physician Ultrasound
Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
干预措施: Ultrasound (Device)
Radiology Tech Ultrasound
Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.
干预措施: Ultrasound (Device)
结局指标
主要结局
Time to Definitive Diagnosis
时间窗: 24 hours
The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart
Emergency Department Length-of-Stay
时间窗: 48 hours
The time the patient is placed in room to the time that the patient is discharged/admitted.
次要结局
未报告次要终点