NICU-TECH RM9L-RS Probe ME Feasibility Study

Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself. An observational study to assess the the clinicians perception of the ultrasound image quality as a tool to detect catheters in vessels.

Study Overview

• Status: Terminated
• Conditions: Neonates

Detailed Description

The intent of the study is to confirm the maximum penetration of the NICU-Tech RM9L-RS probe. The investigators collected images on patients with PIV (Peripheral Intra Venous)/PAC (Peripheral Arterial Catheter) and central line catheters. The investigators collected images of deep vessel structures for offline processing to improve NICU-Tech algorithms for vessel segmentation.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

neonates and infants, from the 23-week gestational (0.5 kg) up to a 6 month old born at term (7 kg), for whom the PIV, PAC, UAC, UVC or PICC catheter insertion is medically indicated.

Description

Inclusion Criteria:

• Neonates that are 23 gestational weeks at birth (and greater than 500 grams) to a 6 month old born infant at term (maximum weight 7 kg) who already have one or more lines placed (PIV/PAC/UVC/UACs/PICC) as part of their medical care. NO INFANT WILL HAVE A LINE PLACE FOR THE PURPOSE OF THIS STUDY

Exclusion Criteria:

• Neonates that are less than 23 gestational weeks at birth
• Neonates that are 23 gestational weeks at birth but are less than 500 grams in weight
• Patients weighing more than 7 kg.-Patients older than 6 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Arm 1: observational ultrasound; Collection of image data with the ultrasound probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants That Fulfilled All Study Procedures.	Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.	1 day (day of procedure)
Vessel Penetration of NICU-Tech RM9L-RS Probe	The algorithmic depth of vessel penetration will be collected.	1 day (day of procedure)

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Jae Kim, MD, UCSD Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: neonates and infants, from the 23-week gestational (0.5 kg); up to a 6 month old born at term (7 kg), for whom the PIV,; PAC, UAC, UVC or PICC catheter insertion is medically; indicated.
• Other Study ID Numbers: NICU-TECH RM9L-RS