跳至主要内容
临床试验/NCT04937868
NCT04937868招募中不适用

Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
12,000
试验地点
1
主要终点
Detection of injuries of major clinical significance

研究概览

简要总结

Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases.

Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies.

This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner:

All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study.

The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.

详细描述

RESEARCH STRATEGY

Significance

Injuries to the abdomen and pelvis can lead to significant morbidity and mortality in adult blunt trauma patients. Clinicians, concerned about abdominal and pelvic injuries, have increasingly utilized abdominal-pelvic (A/P) CT imaging of blunt trauma patients.

CT imaging is compelling because of its documented high sensitivity in detecting injuries, and has lead some to recommend "pan-scan" imaging, which includes head, neck, chest and A/P CT imaging, of all blunt trauma patients. However, well-designed comparative trials have repeatedly failed to demonstrate improved patient outcomes thorough the use of "pan-scanning". It is hard to justify routine imaging if there is no benefit, particularly since A/P CT imaging is expensive and exposes patients to ionizing radiation and risk of lethal malignant transformation. As a consequence, recent recommendations emphasize the use of selective imaging in assessing most trauma patients.

At the present time, there are no definite recommendations to guide selective A/P CT imaging of blunt trauma patients. In current practice, imaging decisions are typically based on clinical judgment, which suffers from poor specificity and substantial variability, making it an imprecise and unreliable tool. A rigorously develop decision instrument could provide substantial benefit in guiding selective A/P CT imaging.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Blunt trauma patients who undergo abdominal-pelvic CT imaging during their initial trauma evaluation in the emergency department.

排除标准

  • 未提供

研究组 & 干预措施

Blunt trauma patients undergoing abdominopelvic computed tomographic imaging

The study will be observational and not alter the care or management of blunt injury victims. Medical decisions will be made by treating physicians using current standards of care. Thus, to reduce the potential for bias, the study will seek to enroll all blunt injury victims who undergo A/P imaging as part of their ED trauma evaluation. This may include children, the elderly, all races, both sexes, and any other demographic or social groups that may present among blunt injury patients. An individual will become eligible for the study when the treating physician determines that A/P CT imaging is needed for their trauma evaluation. Inclusion or exclusion will not be based on age, gender, pregnancy or child-bearing potential, or racial/ethnic origin.

There will be no exclusion criteria.

干预措施: There are no interventions associated with this study (Other)

结局指标

主要结局

Detection of injuries of major clinical significance

时间窗: Initial abdominal-pelvic imaging on the 1 day of presentation.

Injuries of major clinical significance consist of all abdominal and pelvic injuries requiring intervention, as well as any injury to the aorta, and any injury to the spine involving instability or neurological compromise.

Detection of injuries of major or minor clinical importance

时间窗: Initial abdominal-pelvic imaging on the 1 day of presentation.

Detect the presences of all abdominal and pelvic injuries requiring intervention or observation, including all abdominal and pelvic injuries requiring intervention, as well as any injury to the aorta, and any injury to the spine involving instability or neurological compromise.

次要结局

未报告次要终点

研究者

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

William Mower

Professor of Emergency Medicine, David Geffen School of Medicine at UCLA

University of California, Los Angeles

研究点 (1)

Loading locations...

相似试验