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
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
VR Sreekara
Jawaharlal institute of medical education and research