Transvaginal Pelvic Ultrasound in the ED
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in diagnosis before/after pelvic US
研究概览
简要总结
Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology, though its use has not been described in the medical literature. This observational study aims to describe its use in clinical ED practice.
详细描述
Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology. During the pelvic examination a transvaginal ultrasound probe is used to visualize ovarian size, determine echotexture, assess whether ovarian tenderness is present, and sometimes measure ovarian blood flow. Though pelvic ultrasound is used in the Hennepin County Medical Center ED routinely, there is a paucity of literature assessing it's utility.
This observational study will help determine the usefulness of this imaging modality, and how often it changes management in clinical practice.
Specifically, this study will attempt to determine how often transvaginal ultrasound identifies the structures of interest, and then will correlate these findings with the final ED diagnosis. If a formal ultrasound is obtained, the findings of the ED ultrasound will also be compared to the findings of the formal ultrasound.
The treating physicians will be queried the diagnosis and management plans before and after the pelvic US to ascertain changes in management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old female
- •ED bedside transvaginal ultrasound to be performed in a non-pregnant woman with at least one ovary
- •Willing to discuss how they are doing at 7-10 days via phone
- •Valid phone number
排除标准
- •If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound
- •Previously enrolled in this study
结局指标
主要结局
Change in diagnosis before/after pelvic US
时间窗: 8 hours (or less, this will measure what occurs during an ED stay)
The treating physician will be queried the likelihood of EMERGENT and NON-EMERGENT ovarian pathology before and after pelvic US using the following scale: Definite, Probable, Possible, Very Unlikely. The ED tests reviewed before each of these judgements will be noted. EMERGENT is defined as ovarian torsion or tubo-ovarian abscess (TOA). NON-EMERGENT is defined as all other causes, including ovarian cyst, ovarian mass, ovarian malignancy, adnexal mass). The clinician will also free text the most likely diagnosis. A change of two or more levels (eg definite to possible, definite to very unlikely, probable to very unlikely, or vice versa) will be assumed to be a significant change in diagnosis.
Change in management plan before/after pelvic US
时间窗: 8 hours (or less, this will measure what occurs during an ED stay)
The treating physician will choose from the following regarding the management plan before/after the pelvic US: outpatient referral to OB/GYN, formal pelvic US after bedside US, consult GYN in the ED, urgent/emergent operative intervention, None of the above. Any difference in management before/after pelvic US will be considered a significant change in management.
次要结局
- Duration of pelvic US(8 hours (or less, this will measure what occurs during an ED stay))
- Sonographic visualization of ovaries(8 hours (or less, this will measure what occurs during an ED stay))
- Ovary enlargement(8 hours (or less, this will measure what occurs during an ED stay))
- Ovarian tenderness, sonographic(8 hours (or less, this will measure what occurs during an ED stay))
- Ovarian blood flow(8 hours (or less, this will measure what occurs during an ED stay))
- ED disposition after visit(8 hours (or less, this will measure what occurs during an ED stay))
- Final ED diagnosis(8 hours (or less, this will measure what occurs during an ED stay))
- 7-day follow-up(7 days)
- Correlation between ED US and Formal US(8 hours (or less, this will measure what occurs during an ED stay))
- Final impression for ED ultrasound with regards to ovaries(8 hours (or less, this will measure what occurs during an ED stay))
- Formal pelvic US(8 hours (or less, this will measure what occurs during an ED stay))
研究者
Brian Driver
Associate Research Director
Hennepin Healthcare Research Institute