NICU-TECH RM9L-RS Probe ME Feasibility Study

Terminated

• Conditions: Neonates

• Registration Number: NCT01181596
• Lead Sponsor: GE Healthcare

Brief Summary

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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-08-27
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Results First Posted: 2019-08-06
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States