Ultrasound Acute Chest Syndrome Sickle Cell Disease (POCUS)

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

Feasibility and reliability of ultrasound in the inpatient hematology setting.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease; Acute Chest Syndrome
• Intervention / Treatment: Device: Point of Care Ultrasound

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Fisher-Heath, DO; Phone Number: 317-944-8784; Email: tcfisher@iu.edu
• Study Contact Backup: Name: Anne Bubnick, BS; Phone Number: 317-948-0101; Email: abubnick@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Seethal Jacob, MD; Phone Number: 317-278-9662; Email: seejacob@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; Ultrasound days 1, 3, and 5 of hospitalization	Device: Point of Care Ultrasound; Point of Care Ultrasound during hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate	Percentage of patients who are approached for study who agree to be on study	Up to 5 days
Retention rate	Percentage of patients who remain on study	Up to 5 days
Duration of exam	Time taken to complete POCUS examination	Up to 5 days
Acceptability of POCUS by the medical team (physicians and nursing)	Acceptability measured using a 5-point Likert Scale (Strongly Agree to Strongly Disagree) regarding use of POCUS in inpatient setting.	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of point of care ultrasound (POCUS) compared to standard of care (Chest X-ray)	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.	Up to 5 days

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Seethal Jacob, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Sickle Cell Disease; Sickle Cell Anemia; Acute Chest Syndrome; POCUS
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Acute Chest Syndrome
• Other Study ID Numbers: PHO-IIR-POCUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No