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Recruiting

NCT Number: NCT06880679

Ultrasound Acute Chest Syndrome Sickle Cell Disease

Feasibility and reliability of ultrasound in the inpatient hematology setting.

Recruiting

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Key information

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Seethal Jacob, MD

CONTACT

[email protected]

317-278-9662

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

point of care ultrasound

Device

Point of Care Ultrasound during hospitalization

Primary outcomes

  1. Participation rate

    Time frame: Up to 5 days

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

  2. Retention rate

    Time frame: Up to 5 days

    Percentage of patients who remain on study

  3. Duration of exam

    Time frame: Up to 5 days

    Time taken to complete POCUS examination

  4. 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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Bubnick, BS

CONTACT

[email protected]

317-948-0101

Thomas Fisher-Heath, DO

CONTACT

[email protected]

317-944-8784

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: POCUS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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