Acute Chest SyndromePOCUSNCT06880679
Ultrasound Acute Chest Syndrome Sickle Cell Disease
A study testing Point of Care Ultrasound in people with Acute Chest Syndrome and Sickle Cell Disease, run by Indiana University at 1 site in United States.
Trial summary
Feasibility and reliability of ultrasound in the inpatient hematology setting. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Acute Chest Syndrome, Sickle Cell Disease
- What is being tested?
- Point of Care Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Chest Syndrome, Sickle Cell Disease
- Being tested
- Point of Care Ultrasound
- Keywords
- Sickle Cell Disease, Sickle Cell Anemia, Acute Chest Syndrome, POCUS, Ultrasound
- Medical subject headings
- Acute Chest Syndrome, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care UltrasoundDevice
Point of Care Ultrasound during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound days 1, 3, and 5 of hospitalization Receives: Device: Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Percentage of patients who are approached for study who agree to be on study
Measured: Up to 5 days
Retention rate
Percentage of patients who remain on study
Measured: Up to 5 days
Duration of exam
Time taken to complete POCUS examination
Measured: 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.
Measured: Up to 5 days
Secondary outcomes (1)
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.
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start8 Apr 2025
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chest SyndromeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seethal Jacob, MD, MS, Indiana University
- Investigators
- Seethal Jacob, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880679
- Sponsor's protocol ID
- PHO-IIR-POCUS
- Acronym
- POCUS
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Point-of-Care Ultrasound (POCUS) for the Diagnosis of Acute Chest Syndrome in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06880679
- Acronym / sponsor ID
- POCUS / PHO-IIR-POCUS
- Conditions
- Acute Chest Syndrome, Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Sickle Cell Anemia, Acute Chest Syndrome, POCUS, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Point of Care UltrasoundUltrasound days 1, 3, and 5 of hospitalization |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care UltrasoundPoint of Care Ultrasound during hospitalization | Device | Ultrasound |
Primary outcome
Participation rate
Time frame: Up to 5 days
Percentage of patients who are approached for study who agree to be on study
Retention rate
Time frame: Up to 5 days
Percentage of patients who remain on study
Duration of exam
Time frame: Up to 5 days
Time taken to complete POCUS examination
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.
1 secondary outcome
Reliability of point of care ultrasound (POCUS) compared to standard of care (Chest X-ray)
Time frame: Up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seethal Jacob, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of Care Ultrasound in people with Acute Chest Syndrome and Sickle Cell Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: Up to 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.