跳至主要内容
临床试验/CTRI/2025/04/084805
CTRI/2025/04/084805尚未招募不适用

Diagnostic accuracy of point of care ultrasound to identify the source of infection in undifferentiated sepsis patients in the Emergency Department. A Prospective Observational Study

Jawaharlal institute of Postgraduate medical education and research1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
164
试验地点
1
主要终点
To evaluate the diagnostic accuracy of point of care ultrasound protocol to identify the source of infection compared with the final diagnosis

研究概览

简要总结

Patients presenting to the Emergency department with clinically suspected infection will undergo routine clinical workup. After workup patients with undifferentiated sepsis will be screened for our study. Initial workup by the treating physician includes stabilization of patient , history taking, clinical examination.

Undifferentiated sepsis is defined as a septic patient with no obvious infection source identified by history and clinical examination by a treating physician. After obtaining consent, point of care ultrasound protocol will be performed by the investigator as mentioned below.

Consent will be obtained from the patient or legally accepted representative, re consent will be from the patient in the due course if he is able to provide.

The point of care ultrasound protocol is performed routinely as a part of acute management of sick patients in our emergency department. As the study is performed bedside by investigator independently, it will not alter the ongoing resuscitation or delay patient care.

The point of care ultrasound will be carried out by the investigator as briefed in the methodology. The diagnostic ultrasound protocol will be completed in less than 10 minutes duration and will be performed along with patient management. It is ensured that the study procedure will not affect the ongoing patient care.

The final diagnosis obtained by the admitting department will be regarded as the gold standard and will be obtained after reviewing the medical records of the patients for a maximum period of 7 days. It includes all imaging and laboratory data during that hospital stay.

The patient who expire after recruitment and before arriving at the final diagnosis will be excluded from the study.

The consent is taken from the legally accepted representative, if the patient is too sick to give consent,  consent is taken again from the patient in the due course of time as the patient improves.

Point of care ultrasound protocol

 Point of care ultrasound protocol is done using GE healthcare portable machine bedside, it consists of 3 probes

-a cardiac probe - GE 3SC-RS sector array probe with frequency 1-4 MHz

-a linear probe - GE L4-12t-RS wideband linear array probe with frequency 4.2-13MHz

-a convex probe - GE C1-5-RS wideband convex array probe with frequency 1.5-5.0 MHz

Point of care ultrasound is performed by the investigator once the primary treating physician after clinical examination and history concluded the patient as undifferentiated sepsis patient. Point of care ultrasound is performed at all the below mentioned anatomical sites. Point of care ultrasound is performed by the investigator according to the book Ma & Mateer’s Emergency Ultrasound 3 rd edition by O.John Ma, according to the protocol. The competency of the investigator will be assessed by performing at least a minimum of 50 scans before the start of the study.

The source of sepsis is further classified as respiratory, abdominal, urosepsis, musculoskeletal and others

The protocol has been named Sepsis ultrasound protocol to identify source etiology rapidly (SUPER protocol)

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients more than 18 years of age presenting to ED with clinically suspected infection are included in the study The patients included should have no obvious source of infection identified after history and clinical examination by the treating physician.

排除标准

  • Pregnant females Refusal of consent Patient who expires before the admitting team arrives at a final diagnosis.

结局指标

主要结局

To evaluate the diagnostic accuracy of point of care ultrasound protocol to identify the source of infection compared with the final diagnosis

时间窗: 14 days

次要结局

  • To evaluate the sensitivity of diagnosis grouped by the anatomical sites.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

VR Sreekara

Jawaharlal institute of medical education and research

研究点 (1)

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