Portable Ultrasound Monitoring for Premature Infant Monitoring

(POCUS Trial)

Overseen By Daphne Arena Goncharov, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Incarcerated, Fetal anomaly, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 100 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if portable ultrasound devices can help nurses quickly monitor premature babies between 24 and 32 weeks of gestation. The trial compares two methods: continuous fetal monitoring (the usual method) and a handheld ultrasound device. Researchers seek pregnant women carrying a single baby within this gestational age range. Participants will help determine if the portable ultrasound method is faster and more efficient than the standard approach. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance monitoring techniques for premature babies.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that portable ultrasound devices are safe for premature infant monitoring?

Research has shown that handheld ultrasound devices used at the point of care are generally safe and non-invasive. Doctors commonly use these devices in emergency rooms and intensive care units to diagnose and treat patients more quickly. However, detailed information about their safety specifically for newborns remains limited.

Overall, portable ultrasound is considered safe, with no major side effects reported. This makes it a promising tool for monitoring babies without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance fetal monitoring for premature infants. Traditional methods like continuous fetal monitoring (cEFM) involve stationary machines that may not provide real-time flexibility. However, the trial's experimental method uses a Point of Care Handheld Ultrasound. This portable device allows nurses to quickly locate and monitor the fetal heart, potentially making the process faster and more adaptable in various settings. By combining this handheld technology with cEFM, the trial aims to improve the efficiency and effectiveness of fetal monitoring, offering a promising advance over current standard practices.

What evidence suggests that using portable ultrasound devices is effective for premature infant monitoring?

Research shows that Point of Care Handheld Ultrasound, one method studied in this trial, promises faster and more accurate monitoring. Studies indicate it effectively provides quick bedside images, especially useful in NICUs (Neonatal Intensive Care Units). This method helps nurses locate the baby's heart swiftly, speeding up the connection to monitoring devices. Evidence-based guidelines support its use for very sick newborns, suggesting it can enhance care. This approach is gaining popularity because it reduces wait times and improves monitoring accuracy, crucial for premature babies. Meanwhile, Continuous Fetal Monitoring, another method under study, remains a standard practice for fetal monitoring. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 to 50 with a single baby between 24 and 32 weeks of gestation. It's not suitable for those outside this pregnancy window, under age 18, if the fetus has a known lethal anomaly where monitoring was declined, or if they are incarcerated.

Inclusion Criteria

I am a woman aged between 18 and 50.

Gestational age between 24 weeks 0 days and 32 weeks 0 days

Singleton pregnancy

Exclusion Criteria

I am under 18 years old.

I have chosen not to monitor my fetus known to have a lethal condition.

Incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Nurses use handheld ultrasound devices to assist with applying continuous external fetal monitoring (cEFM) in early preterm pregnancies

Up to 100 days

Continuous monitoring during triage visits

Follow-up

Participants are monitored for the time to successful detection of fetal heart rate and any need for physician intervention

Up to 100 days

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Fetal Monitoring
• Point of Care Handheld Ultrasound

Trial Overview

The study is examining whether nurses using handheld ultrasound devices can speed up the process of fetal monitoring on babies from ages of gestational weeks 24 to 32 compared to standard procedures.

How Is the Trial Designed?

Group I: Point of Care Handheld Ultrasound Experimental Treatment 1 Intervention

A nurse will turn on the Obix cEFM machine which will automatically register the patient in the Obix system and begin the timer which will be used to measure time to fetal monitoring. The patient will lay on the triage stretcher and a Butterfly ultrasound (Figure 1) probe will be used with a secure institutional Ipad by the triage nurse to identify the fetal position and location of the fetal heart. All images are deidentified and not stored since it will be a live real time aid to obtain a fetal heart tracing via cEFM. The cEFM will be placed on the maternal abdomen according to the imaging obtained by the ultrasound. Once fetal heart rate signal is obtained via cEFM, the patient's participation in the study ends.

Group II: Continuous Fetal Monitoring Active Control 1 Intervention

A nurse will turn on the Obix cEFM machine which will automatically register the patient in the Obix system and begin the timer which will be used to measure time to fetal monitoring. The patient will lay on the triage stretcher and the continuous external fetal monitor doppler probe will be placed on the abdomen over the fetus, identified via Leopold maneuvers. Nurses will adjust the cEFM as needed until a full fetal heart rate signal is obtained. At this point the timer will be counted as the time to monitor. Once the fetal heart rate signal is obtained via cEFM, the patient's participation in the study ends.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Published Research Related to This Trial

Point of Care Ultrasound (POCUS) is a valuable tool in pediatric emergency care, providing a non-invasive and reproducible method for assessing injuries in children, including detecting free fluid, pneumothoraces, and fractures.

The review highlights the need for clear guidelines on when and how to use POCUS effectively, as well as the importance of establishing training standards for healthcare providers to ensure its optimal use in injured pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Point of Care Ultrasound in the Injured Paediatric Patient. Istasy, V., Thompson, D., Belisle S, S., et al.[2018]

Pocket-sized ultrasound devices, known as 'echoscopes', are emerging as valuable tools in clinical settings, particularly in cardiology, gynecology, and gastroenterology, with expectations for improved image quality and expanded techniques in the future.

Echoscopy, a form of point-of-care ultrasound (POCUS), is being promoted by the European Federation of Societies of Ultrasound in Medicine and Biology (EFSUMB), which has developed teaching materials to help clinicians integrate this technology into their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Echoscopy]. Dietrich, CF., Hocke, M., Braden, B.[2016]

The POCUS Working Group of ESPNIC developed evidence-based guidelines for using point-of-care ultrasound in critically ill neonates and children, reaching consensus on 39 out of 41 recommendations.

Most recommendations (28 out of 39) were based on moderate quality evidence, highlighting the need for further research and training to enhance the effectiveness and safety of POCUS in pediatric critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International evidence-based guidelines on Point of Care Ultrasound (POCUS) for critically ill neonates and children issued by the POCUS Working Group of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). Singh, Y., Tissot, C., Fraga, MV., et al.[2021]

A newly developed ultra-portable ultrasound device, costing around $3000, offers comparable image quality to standard diagnostic echo machines for assessing cardiac function in patients, making it a promising tool for screening.

In a study involving 69 cardiac patients, the left ventricular ejection fraction measured by the portable device closely matched that obtained from traditional machines, indicating its potential efficacy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an ultra-portable echo device connected to USB port. Saijo, Y., Nitta, S., Kobayashi, K., et al.[2016]

The portable EchoScope device demonstrated good or sufficient image quality in 97.4% of cases, making it effective for detecting abdominal pathologies, particularly focal lesions larger than 20 mm.

In a study of 231 patients, the EchoScope successfully detected 97% of abdominal focal lesions, showing comparable results to high-end ultrasound systems, indicating its potential for widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EchoScopy in scanning abdominal diseases: initial clinical experience. Barreiros, AP., Cui, XW., Ignee, A., et al.[2016]

A study involving 300 patients demonstrated that the handheld ultrasound device, EchoScope, provided good or sufficient image quality in 88% of cases, making it effective for detecting various abdominal conditions.

The EchoScope successfully identified 78% of abdominal focal lesions, indicating its potential as a portable and affordable alternative to high-end ultrasound systems for specific diagnostic purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EchoScopy in scanning abdominal diseases; a prospective single center study. Barreiros, AP., Dong, Y., Ignee, A., et al.[2019]

Point of care ultrasound (POCUS) is a valuable tool in pediatric emergency medicine, particularly for diagnosing and assessing respiratory issues in children of all ages, from neonates to older kids.

The article emphasizes the practical benefits of using POCUS in everyday pediatric practice, including its ability to provide immediate diagnostic information and evaluate the effectiveness of treatments for respiratory distress and failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifteen-minute consultation: Using point of care ultrasound to assess children with respiratory failure. Ord, HL., Griksaitis, MJ.[2020]

Point-of-care ultrasound (POCUS) is increasingly being used in pediatric emergency medicine and critical care, showing effectiveness in diagnosing and managing conditions like respiratory distress, trauma, and dehydration.

The technology is evolving to include new applications such as diagnosing pneumonia, guiding resuscitation, and monitoring intracranial pressure, highlighting the need for formal training to standardize its use among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions in point-of-care ultrasound at the crossroads of paediatric emergency and critical care. Bortcosh, W., Shaahinfar, A., Sojar, S., et al.[2018]

Point-of-care ultrasound (POCUS) is becoming an important tool in neonatal intensive care units (NICUs) for diagnosing and monitoring conditions like pulmonary diseases, hemodynamic instability, and intraventricular hemorrhage, among others.

There is a growing need for formal training and standardized guidelines for the use of POCUS in neonatology to ensure its effective and safe application across different medical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care ultrasound in the neonatal ICU. Miller, LE., Stoller, JZ., Fraga, MV.[2021]

This case report highlights the novel use of point-of-care ultrasound (POCUS) to diagnose fetal intracranial hemorrhage in a pregnant trauma patient at the initial presentation, which has not been documented in previous literature.

The study emphasizes the potential of POCUS as a valuable tool for immediate assessment of fetal injury in trauma situations, suggesting it could improve outcomes for both mother and fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic Fetal Intracranial Hemorrhage Suggested by Point-of-Care Ultrasound. Mooney, NC., Wu, L., Vrablik, ME.[2020]

Point of care ultrasound (POCUS) is becoming increasingly popular among emergency and acute care physicians, allowing them to use this safe and non-invasive tool to improve patient management.

The availability of portable ultrasound machines has made it easier for non-radiologists to incorporate POCUS into their practice, enhancing diagnostic capabilities in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curriculum mapping for Focused Acute Medicine Ultrasound (FAMUS). Alber, KF., Dachsel, M., Gilmore, A., et al.[2018]

Portable ultrasound is an effective imaging method for assessing rib fractures, providing quick and economical evaluations that can benefit elderly patients.

Using portable ultrasound in the operating room allows for smaller incisions, reducing the risk of complications like infections, which is particularly important for vulnerable patients such as the 86-year-old case presented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a portable ultrasound system in the surgical assessment of rib fractures in an elderly patient. Martin, VT., Zeng, L., Nzengue, JC., et al.[2022]

Point of care ultrasound (POCUS) is being increasingly used to assess the volume status and major vasculature of trauma patients upon their arrival, which can help guide immediate treatment decisions.

POCUS has also proven effective in identifying pneumothorax in trauma patients, enhancing diagnostic capabilities in emergency settings, and guidelines for its use are being established by organizations like ASA and ASRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Ultrasound for the Trauma Anesthesiologist. Heinz, ER., Vincent, A.[2022]

In a half-year observational study, pediatric surgeons performed 51 point-of-care ultrasound (POCUS) exams, primarily to assess intraabdominal and subcutaneous collections, demonstrating its practical utility in pediatric surgery.

Despite a high reliance on formal diagnostic studies (65%), the results of POCUS were highly compatible (92%) with those from traditional imaging methods, indicating that POCUS can effectively complement standard diagnostic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Ultrasound in a Department of Pediatric and Adolescent Surgery. Avinadav, E., Almog, A., Kravarusic, D., et al.[2018]

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pmc.ncbi.nlm.nih.gov/articles/PMC12057456/

Comparison of Six Handheld Ultrasound Devices by ...

Most importantly, the three highest ranking handhelds — Kosmos™, Lumify™, and Vscan Air™ — had more positive than negative comments, while ...

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ccforum.biomedcentral.com

ccforum.biomedcentral.com/articles/10.1186/s13054-020-2787-9

International evidence-based guidelines on Point of Care ...

Evidence-based guidelines for the use of POCUS in critically ill neonates and children are now available. They will be useful to optimise the use of POCUS.

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publications.aap.org

publications.aap.org/pediatrics/article/150/6/e2022060052/190109/Use-of-Point-of-Care-Ultrasonography-in-the-NICU

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This clinical report describes the current landscape of neonatal POCUS, outlines barriers for implementation, and provides a suggested educational framework.

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pmc.ncbi.nlm.nih.gov/articles/PMC9393648/

Handheld Point-of-Care Ultrasound: Safety Considerations for ...

HPOCUS can be a powerful tool for expedited diagnosis and management guidance. However, there is limited data regarding patient safety and current regulatory ...

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withpower.com/trial/phase-ultrasounds-8-2023-8d9a8

Portable Ultrasound Monitoring for Premature Infant ...

The available research suggests that point-of-care ultrasound (POCUS) is considered a safe and non-invasive tool widely used in emergency, intensive care, ...

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apsf.org

apsf.org/article/portable-point-of-care-ultrasound-ppocus-an-emerging-technology-for-improving-patient-safety/

Portable Point of Care Ultrasound (PPOCUS)

PPOCUS which involves the use of handheld, portable, affordable, easy-to-use ultrasound devices to perform point of care ultrasound (POCUS) is an emerging ...