Ultrasound Acute Chest Syndrome Sickle Cell Disease

Not Applicable

Recruiting

• Conditions: Acute Chest Syndrome; Sickle Cell Disease

• Registration Number: NCT06880679
• Lead Sponsor: Indiana University

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 Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-18
• Status Verified: 2025-04
• Study Start: 2025-04-08
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Participation rate	Up to 5 days	Percentage of patients who are approached for study who agree to be on study
Retention rate	Up to 5 days	Percentage of patients who remain on study
Duration of exam	Up to 5 days	Time taken to complete POCUS examination
Acceptability of POCUS by the medical team (physicians and nursing)	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 Outcome Measures

Name	Time	Method
Reliability of point of care ultrasound (POCUS) compared to standard of care (Chest X-ray)	Up to 5 days	A positive screening of acute chest syndrome by POCUS is identification of either a lung consolidation or focal B-lines. POCUS findings will be compared to standard of care (Chest X-ray) findings to see if findings concur.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States