NICU-TECH RM9L-RS Probe ME Feasibility Study

General Electric (GE)

Status: Terminated

Conditions: Neonates

Study type: Observational

Funder types: Industry

Identifiers

NCT01181596

NICU-TECH RM9L-RS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 23 weeks to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 1 patient group

Arm 1: observational ultrasound

Description:

Collection of image data with the ultrasound probe.