Ultrasound for Acute Chest Syndrome

(POCUS Trial)

Overseen By Anne Bubnick, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Hemodynamically unstable, ACS diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and reliability of ultrasound in detecting acute chest syndrome, a serious lung condition, in individuals with sickle cell disease. Participants will undergo ultrasound on days 1, 3, and 5 of their hospital stay. The trial targets those aged 0 to 25 who are hospitalized due to complications from sickle cell disease, including any sickle cell crisis requiring hospital care. The study aims to determine if bedside ultrasound (point-of-care ultrasound) is a practical diagnostic tool for these patients. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance diagnostic methods for sickle cell disease patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ultrasound is safe for use in the inpatient hematology setting?

Research has shown that point of care ultrasound (POCUS) safely and effectively diagnoses conditions like acute chest syndrome. Studies have found POCUS to be highly accurate, with a 92% accuracy rate, 88% sensitivity, and 93% specificity. This reliability allows it to identify problems without causing harm. No reports of negative effects from using ultrasound in these situations make it a safe choice for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Acute Chest Syndrome, like oxygen therapy, blood transfusions, and antibiotics, aim to manage symptoms and prevent complications. However, the use of Point of Care Ultrasound is unique because it provides a non-invasive way to quickly evaluate lung conditions right at the bedside. Unlike traditional imaging methods that require transferring patients to different facilities, ultrasound can be done directly in the hospital room, allowing for faster decision-making. Researchers are excited about this approach because it could lead to quicker diagnoses and potentially improve patient outcomes by tailoring treatments more precisely during critical points of hospitalization.

What evidence suggests that ultrasound is effective for acute chest syndrome?

Research has shown that Point of Care Ultrasound (POCUS), which participants in this trial will receive, effectively spots acute chest syndrome. In several studies, POCUS demonstrated 92% accuracy in detecting this condition, correctly identifying 88% of individuals with the condition and 93% of those without it. These findings suggest that POCUS is a reliable tool for diagnosing acute chest syndrome, particularly in patients with chest pain or breathing difficulties. Using POCUS can enable healthcare providers to make quicker and more accurate diagnoses, potentially leading to faster treatment for patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Seethal Jacob, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This clinical trial is open to individuals who have been diagnosed with conditions such as Acute Coronary Syndrome or Sickle Cell Disease, specifically those experiencing Acute Chest Syndrome. The study seems to focus on patients in a hospital setting under the care of a hematology team.

Inclusion Criteria

I have been diagnosed with sickle cell disease.

I was hospitalized for a sickle cell disease complication.

I am 25 years old or younger.

Exclusion Criteria

Patient is considered hemodynamically unstable to undergo consent and study procedures

POCUS operator not available

I was diagnosed with acute coronary syndrome before being admitted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo ultrasound on days 1, 3, and 5 of hospitalization to diagnose acute chest syndrome

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ultrasound diagnosis

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Point of Care Ultrasound

Trial Overview The trial is testing the feasibility and reliability of using point-of-care ultrasound for patients with certain cardiovascular and blood disorders while they are admitted to the hospital.

How Is the Trial Designed?

Group I: Ultrasound Experimental Treatment 1 Intervention

Ultrasound days 1, 3, and 5 of hospitalization

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10258441/

Diagnostic Test Accuracy of Lung Ultrasound for Acute ... Take-home Points.​​ Results: From six studies and out of 625 patients, 97% of whom were 21 years old or younger, the summary sensitivity was 0.92 and the summary ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064420306570

Utility of Point-of-Care Lung Ultrasonography for ... Accuracy of point-of-care lung ultrasonography to detected acute chest syndrome was 92%, sensitivity was 88%, and specificity was 93% compared with that for ...

3. annemergmed.com annemergmed.com/article/S0196-0644(20)30657-0/fulltext

Utility of Point-of-Care Lung Ultrasonography for ... Our results demonstrate that point-of-care lung ultrasonography is able to identify acute chest syndrome with high accuracy, sensitivity, and specificity. It ...

4. withpower.com withpower.com/trial/phase-acute-chest-syndrome-2-2025-84e4a

Ultrasound for Acute Chest Syndrome (POCUS Trial) Research shows that Point of Care Ultrasound (POCUS) can help quickly diagnose conditions related to chest pain and breathing problems, which may lead to faster ...

5. ultrasoundgel.org ultrasoundgel.org/posts/ygBFxhg643qRb0BSsgu-_g

Lung Ultrasound for Acute Chest Syndrome POCUS was able to detect ACS with high sensitivity and specificity compared with CXR. Using POCUS on this patient population was well-received ...

6. annemergmed.com annemergmed.com/article/S0196-0644(20)30657-0/abstract

Utility of Point-of-Care Lung Ultrasonography for ... Accuracy of point-of-care lung ultrasonography to detected acute chest syndrome was 92%, sensitivity was 88%, and specificity was 93% compared with that for ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S095362052500233X

Point of care ultrasound: focus on evidence for a critical ... A recent meta-analysis evaluated the accuracy of cardiac ultrasound for diagnosing acute myocardial ischemia in patients presenting to the ED ...

8. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)00156-3/fulltext

Lung Ultrasound in Sickle Cell - CHEST Journal In older children and adults, a single severe ACS episode precedes respiratory failure and multiorgan failure syndrome, with a high mortality rate (9% to 16%).

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06880679?term=AREA%5BBasicSearch%5D(Sickle%20Cell%20Anaemia)&rank=8

Ultrasound Acute Chest Syndrome Sickle Cell Disease 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 ...