NICU-TECH RM9L-RS Probe ME Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01181596
First received: August 12, 2010
Last updated: February 9, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Neonates
Device: ultrasound probing
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: NICU-TECH RM9L-RS Probe ME Feasibility Study

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Determine the feasibility of the RM9L-RS US probe and catherter placement [ Time Frame: 6 months ]
    Determine the feasibility of the RM9L-RS ultrasound probe current design yeilds depth of penetration that is satisfactory for seeing catherter in peripheral vessels and catheter tips in central vessels.


Enrollment: 32
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ultrasound probing
    Ultrasound probing and imaging data collection.
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   23 Weeks to 6 Months
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181596

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Jae Kim, MD UCSD Medical Center
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01181596     History of Changes
Other Study ID Numbers: NICU-TECH RM9L-RS
Study First Received: August 12, 2010
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
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.

ClinicalTrials.gov processed this record on April 21, 2014