Ultrasound Acute Chest Syndrome Sickle Cell Disease (POCUS)

August 31, 2026 updated by: Seethal Jacob, MD, MS, Indiana University

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 5 days
Percentage of patients who are approached for study who agree to be on study
Up to 5 days
Retention rate
Time Frame: Up to 5 days
Percentage of patients who remain on study
Up to 5 days
Duration of exam
Time Frame: Up to 5 days
Time taken to complete POCUS examination
Up to 5 days
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.
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)
Time Frame: 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.
Up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Seethal Jacob, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Actual)

May 6, 2026

Study Completion (Actual)

May 6, 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)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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