NICU-TECH RM9L-RS Probe ME Feasibility Study

NCT01181596 | Terminated Results

• 1 other identifier: NICU-TECH RM9L-RS
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonates

Keywords

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.

Outcome Measures

Primary Outcomes (2)

• 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)

• Vessel Penetration of NICU-Tech RM9L-RS Probe

  The algorithmic depth of vessel penetration will be collected.

  1 day (day of procedure)

Study Arms (1)

Arm 1: observational ultrasound

Collection of image data with the ultrasound probe.

Eligibility Criteria

• Age: 23 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrollment was stopped early/terminated, study development stopped and no results were analyzed.

Results Point of Contact

• Title: Jae Kim, MD
• Organization: University of California - San Diego

neojae@ucsd.edu

619-543-3759

Study Officials

• Jae Kim, MD

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 6, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-06

Locations

US (1)