Ultrasound Acute Chest Syndrome Sickle Cell Disease

NCT06880679 | Recruiting FDA Device

• 1 other identifier: PHO-IIR-POCUS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility and reliability of ultrasound in the inpatient hematology setting.

Conditions

Acute Chest Syndrome; Sickle Cell Disease

Keywords

Sickle Cell Disease; Sickle Cell Anemia; Acute Chest Syndrome; POCUS; Ultrasound

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  Up to 5 days

Study Arms (1)

Ultrasound

EXPERIMENTAL

Ultrasound days 1, 3, and 5 of hospitalization

Device: Point of Care Ultrasound

Interventions

Point of Care Ultrasound DEVICE

Point of Care Ultrasound during hospitalization

Ultrasound

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Acute Chest Syndrome; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Seethal Jacob, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Fisher-Heath, DO

CONTACT

317-944-8784; tcfisher@iu.edu

Anne Bubnick, BS

CONTACT

317-948-0101; abubnick@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 18, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)