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NICU-TECH RM9L-RS Probe ME Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181596
Recruitment Status : Terminated (Images not adequate to visualize catheter penetration or obtain measurements)
First Posted : August 13, 2010
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: NICU-TECH RM9L-RS Probe ME Feasibility Study
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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



Primary Outcome Measures :
  1. Participants That Fulfilled All Study Procedures. [ Time Frame: 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.

  2. Vessel Penetration of NICU-Tech RM9L-RS Probe [ Time Frame: 1 day (day of procedure) ]
    The algorithmic depth of vessel penetration will be collected.



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181596


Locations
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United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
GE Healthcare
Investigators
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Principal Investigator: Jae Kim, MD UCSD Medical Center
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01181596    
Other Study ID Numbers: NICU-TECH RM9L-RS
First Posted: August 13, 2010    Key Record Dates
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019
Last Verified: June 2019
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.