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Clinical Trials/CTRI/2025/04/084805
CTRI/2025/04/084805
Not yet recruiting
Not Applicable

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 site in 1 country164 target enrollmentStarted: April 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
164
Locations
1
Primary Endpoint
To evaluate the diagnostic accuracy of point of care ultrasound protocol to identify the source of infection compared with the final diagnosis

Overview

Brief Summary

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)

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 14 days

Secondary Outcomes

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

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

VR Sreekara

Jawaharlal institute of medical education and research

Study Sites (1)

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