Point of Care Ultrasound in Obstetric Triage

Ultrasound Clinical Trial

— POCUS  

Official title:

Handheld Point of Care Ultrasound in Obstetric Triage: A Cluster Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938790
• Other study ID #: 22-0220
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: February 16, 2025

Study information

• Verified date: March 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Daphne Arena Goncharov, MD
• Phone: 409-266-6917
• Email: ddarena[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research will find out if using portable ultrasound devices by nurses can make it quicker to get babies from 24 to 32 weeks on the doppler monitor.

Description:

In an acute obstetric unit such as labor and delivery triage, rapid determination of fetal status is crucial for optimal fetal outcomes. In most units, nursing staff holds the initial role of patient care for both mother and fetus. The expeditious and efficient application of external fetal monitoring (cEFM) acts as the cornerstone of fetal assessment in triage; however, factors such as early gestational age or maternal habitus may make an assessment with doppler alone challenging. The limited availability of physicians to assess with large, mobile bedside ultrasound units in these cases results in delays in care and decreases efficiency on the unit. Advanced ultrasound technology allows for the ready availability of point-of-care ultrasound devices using probes that connect to portable electronics through applications. Studies performed in low-resource and remote areas have demonstrated the utility of training nursing staff to perform point-of-care ultrasound (PoCUS); however, the literature needs to include studies performed at major academic centers. The study aims are to determine if the utilization of handheld PUM by nursing staff, as an ancillary tool to assist with applying cEFM in early preterm pregnancies, leads to decreased delays in the successful application of cEFM. The Butterfly Portable Ultrasound Device will be used for this study, which is a PUM that is lightweight, ultraportable and generates quality images equal to or better than the current larger SonoSite devices available. Secondary outcomes will examine the need for physician exams with bedside portable SonoSite ultrasound to apply cEFM as well as time to bedside once a physician is called for evaluation with bedside SonoSite.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: February 16, 2025
• Est. primary completion date: February 16, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Patients will be included in the study if they meet the following criteria:

• Women maternal age 18 to age 50
• Gestational age between 24 weeks 0 days and 32 weeks 0 days
• Singleton pregnancy. Exclusion Criteria:

Patients will be excluded if:

• They are incarcerated
• Outside the gestational window for inclusion
• Are below the age of 18
• If the fetus has a known lethal anomaly and a decision has been made by the patient to decline fetal monitoring.

Related Conditions & MeSH terms

• Fetal Monitoring
• Ultrasound

Intervention

Other:
• Continuous Fetal Monitoring
Fetal doppler used to monitor fetal heart rate in triage
• Point of Care Handheld Ultrasound
Point of Care Handheld Ultrasound

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to signal of fetal heart rate	How long does it take for the external fetal monitor to pick up a continuous fetal heart rate signal. From time fetal monitor is turned on to the successful detection of fetal heart rate, recorded in minutes and seconds up to 100 days.	From date of randomization until the date of first successful detection of fetal heart rate up to 100 days
Secondary	Physician paged to bedside	Time to bedside from when a physician is called for assessment. For each occurrence a physician is called to bedside, from time physician is contacted to time physician arrives at bedside recorded in minutes and seconds up to 100 days	From date of randomization until the date of first successful detection of fetal heart rate up to 100 days