NICU-TECH RM9L-RS Probe ME Feasibility Study

Neonates Clinical Trial

Official title:

NICU-TECH RM9L-RS Probe ME Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01181596
• Other study ID #: NICU-TECH RM9L-RS
• Status: Terminated
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Neonates

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Vessel Penetration of NICU-Tech RM9L-RS Probe	The algorithmic depth of vessel penetration will be collected.	1 day (day of procedure)