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临床试验/NCT01763840
NCT01763840已完成1 期

Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

David Mooney1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
David Mooney
入组人数
18
试验地点
1
主要终点
Primary outcome measured will be the identification of intra-abdominal injury

研究概览

简要总结

The research protocol aims to compare the utility of contrast enhanced abdominal sonography with computerized tomography in the evaluation of children with blunt abdominal trauma. Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the trauma service with a CT scan of abdomen & pelvis already performed at the referring institution will be identified by the trauma service as eligible for inclusion.

The ultrasounds will be performed by one of two Attending Radiologists involved in the study. The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal and pelvic solid tumors. The contrast enhanced ultrasound will be performed by radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be monitored for 30 minutes after the contrast agent is given and any adverse reactions will be recorded. Adverse reactions to Optison have occurred within this time frame in the literature. Subsequent medical care will be as indicated per the clinical practice guideline.

详细描述

Contrast enhanced ultrasound has been used clinically in Europe for the past 10 years as an evaulation tool for examining abdominal injuries in trauma among children and adults. This is a valuable diagnostic modality that could potentially reduce the need for radiation exposure from abdominal computed tomography (CT) scans in trauma evaluation. The research protocol aims to compare the utility of contrast enhanced abdominal sonography with computerized tomography in the evaluation of children with blunt abdominal trauma. Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the trauma service with a CT scan of abdomen & pelvis already performed at the referring institution will be identified by the trauma service as eligible for inclusion. Children who are hemodynamically unstable, known cardiac abnormality, unable to roll over, or unable to assent will be excluded from the study. If the child is enrolled in the study, he/she will have a non contrast ultrasound, followed by a contrast enhanced ultrasound performed in the Radiology Department once he/she is stabilized and evaluation is completed in the Emergency Room. The patient will have vital signs (including blood pressure, heart rate, respiratory rate, oxygen saturation) monitored during the study and 30 minutes after contrast administration.

The ultrasounds will be performed by one of two Attending Radiologists involved in the study. The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal and pelvic solid tumors. After the non contrast ultrasound is performed, the Optison contrast agent will be given via peripheral IV. The contrast enhanced ultrasound will be performed by radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be monitored for 30 minutes after the contrast agent is given and any adverse reactions will be recorded. Adverse reactions to Optison have occurred within this time frame in the literature. Subsequent medical care will be as indicated per the clinical practice guideline.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
2 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Hemodynamically stable
  • Age 10-18 years
  • Transferred to BCH Emergency Department to the Trauma Service for evaluation and management
  • Concern for blunt abdominal injury
  • CT A/P performed at referring institution
  • Planned for admission to the hospital on the trauma service

排除标准

  • Patients who are hemodynamically unstable
  • Known cardiac abnormality
  • Pulmonary hypertension
  • Known sensitivity to human albumin or blood products
  • Unable to roll over
  • Unable to assent
  • Lactating

研究组 & 干预措施

Contrast enhanced Ultrasound

Experimental

Presence and grade of solid organ injury on contrast enhanced ultrasound

干预措施: Contrast enhanced Ultrasound (Drug)

结局指标

主要结局

Primary outcome measured will be the identification of intra-abdominal injury

时间窗: Baseline

次要结局

  • Secondary outcome will be assessment of grade of solid organ injury.(Baseline)

研究者

发起方
David Mooney
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Mooney

Associate Professor of Surgery

Boston Children's Hospital

研究点 (1)

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