Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections
Emergency Bedside Ultrasound for the Evaluation of Soft Tissue Infections in the Pediatric Emergency Department
연구 개요
상세 설명
Skin and soft tissue infections, particularly abscesses caused by community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA) are a growing public health problem. The treatment of a skin abscess usually requires incision and drainage or needle aspiration. In addition to providing definitive therapy, appropriate drainage can allow for organism identification and antibiotic susceptibility testing should antibiotics be utilized. A skin cellulitis, which is treated with systemic antibiotics and supportive care alone, may be hard to distinguish from an abscess, as both have similar clinical features. Therefore, as the presence or absence of purulent material may be difficult to determine, children may undergo an unnecessary drainage procedure. If drainage is avoided, the patient may require a subsequent ED visit if the diagnosis is missed on initial examination. This can lead to worsened clinical outcome, an extra financial burden for the family, and added emotional distress for the patient.
Bedside emergency ultrasound (EUS), which has been used since the mid-1980s is being used in adults to detect fluid collections such as soft tissue abscesses. Studies in adult patients have shown that EUS adds useful information to the history and physical examination and may even alter physicians' clinical impressions and management of patients. Currently, it is not known whether children represent a different population for EUS than adults and how EUS would perform in the pediatric outpatient setting. With improved diagnosis of soft tissue infections, better epidemiologic data about organism prevalence, improved and more prompt treatment, and more appropriate use of antibiotic therapy can be done.
To date, no study exists evaluating its utility specifically for the evaluation of soft tissue infections in pediatric patients. The goal of this study is to evaluate the test characteristics of EUS in pediatric patients presenting with evidence of soft tissue infection.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- The Children's Hospital of Philadelphia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Evidence of at least one of the following: skin elevation, induration, tenderness, fluctuance, or history of purulent drainage from the lesion
Exclusion Criteria:
- Suspected paronychia or felon
- Lesion involving the face, perirectal, or vaginal area
- Surgical wound infection
- Underlying immunodeficiency
- Non-soft tissue infectious mass (e.g. lymphadenitis)
- Suspected non-infectious mass (e.g. hernia, lymph node)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Ultrasound
One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
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Ultrasound will be performed on the lesion in question.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.
기간: 18 mos
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The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.
Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.
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18 mos
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elizabeth Alpern, MD, MSCE, Children's Hospital of Philadelphia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Bedside emergency ultrasound에 대한 임상 시험
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Ajou University School of Medicine종료됨
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University Hospital Heidelberg알려지지 않은
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University Hospital Heidelberg완전한
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Harvard School of Public Health (HSPH)Bill and Melinda Gates Foundation; Institute for Clinical Effectiveness and Health Policy; Addis Continental Institute of Public Health 그리고 다른 협력자들완전한