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Clinical Trials/NCT06880679
NCT06880679
Recruiting
Not Applicable

Use of Point-of-Care Ultrasound (POCUS) for the Diagnosis of Acute Chest Syndrome in Patients With Sickle Cell Disease

Indiana University1 site in 1 country30 target enrollmentStarted: April 8, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Participation rate

Overview

Brief Summary

Feasibility and reliability of ultrasound in the inpatient hematology setting.

Detailed Description

Acute chest syndrome (ACS) is a complication of sickle cell disease where individuals have symptoms of fever, low oxygen levels or difficulty breathing in the setting of a new lung finding on chest x-ray. Chest x-ray is a useful tool to identify it but has some side effects. The investigators think ultrasound will be an equally feasible, reliable tool and minimize some of the side effects associated with chest x-ray. Ultrasound is a non-invasive was to obtain an image that does not require radiation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
— to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age: 0-25 years old
  • Diagnosis: Patients with a documented diagnosis of sickle cell disease (any genotype)
  • Disposition: Hospitalized for a SCD-related complication (e.g. VOC)

Exclusion Criteria

  • Patient is considered hemodynamically unstable to undergo consent and study procedures
  • Already has diagnosis of ACS prior to admission to inpatient unit
  • POCUS operator not available

Arms & Interventions

Ultrasound

Experimental

Ultrasound days 1, 3, and 5 of hospitalization

Intervention: Point of Care Ultrasound (Device)

Outcomes

Primary Outcomes

Participation rate

Time Frame: Up to 5 days

Percentage of patients who are approached for study who agree to be on study

Retention rate

Time Frame: Up to 5 days

Percentage of patients who remain on study

Duration of exam

Time Frame: Up to 5 days

Time taken to complete POCUS examination

Acceptability of POCUS by the medical team (physicians and nursing)

Time Frame: Up to 5 days

Acceptability measured using a 5-point Likert Scale (Strongly Agree to Strongly Disagree) regarding use of POCUS in inpatient setting.

Secondary Outcomes

  • Reliability of point of care ultrasound (POCUS) compared to standard of care (Chest X-ray)(Up to 5 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seethal Jacob, MD, MS

Associate Professor of Pediatrics

Indiana University

Study Sites (1)

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