NICU-TECH RM9L-RS Probe ME Feasibility Study
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arm 1: observational ultrasound Collection of image data with the ultrasound probe. |
Outcome Measures
Primary Outcome Measures
- Participants That Fulfilled All Study Procedures. [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.
- Vessel Penetration of NICU-Tech RM9L-RS Probe [1 day (day of procedure)]
The algorithmic depth of vessel penetration will be collected.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSD Medical Center | San Diego | California | United States | 92103 |
Sponsors and Collaborators
- GE Healthcare
Investigators
- Principal Investigator: Jae Kim, MD, UCSD Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NICU-TECH RM9L-RS
Study Results
Participant Flow
| Recruitment Details | This is an observational study where recruitment took place in the Neonatal Intensive Care Unit. Enrollment period of June 2010 - November 2011. |
|---|---|
| Pre-assignment Detail | If participants health worsens prior to assignment they were excluded from the study. |
| Arm/Group Title | Ultrasound Probing |
|---|---|
| Arm/Group Description | Ultrasound probing to guide catheter placement |
| Period Title: Overall Study | |
| STARTED | 31 |
| COMPLETED | 31 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Ultrasound Probing |
|---|---|
| Arm/Group Description | Ultrasound probing to guide catheter placement |
| Overall Participants | 31 |
| Age (Count of Participants) | |
| <=18 years |
31
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
0.5
(.02)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
15
48.4%
|
| Male |
16
51.6%
|
Outcome Measures
| Title | Participants That Fulfilled All Study Procedures. |
|---|---|
| Description | Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place. |
| Time Frame | 1 day (day of procedure) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study participants who have one or more catheters in place. |
| Arm/Group Title | Arm 1: Observational Ultrasound |
|---|---|
| Arm/Group Description | Collection of image data with the ultrasound probe. |
| Measure Participants | 31 |
| Count of Participants [Participants] |
31
100%
|
| Title | Vessel Penetration of NICU-Tech RM9L-RS Probe |
|---|---|
| Description | The algorithmic depth of vessel penetration will be collected. |
| Time Frame | 1 day (day of procedure) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Images were not adequate to visualize catheter penetration, or to obtain measurements. |
| Arm/Group Title | Ultrasound Probing |
|---|---|
| Arm/Group Description | Ultrasound probing to guide catheter placement |
| Measure Participants | 0 |
Adverse Events
| Time Frame | 1.5 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Ultrasound Probing | |
| Arm/Group Description | Ultrasound probing to guide catheter placement | |
All Cause Mortality |
||
| Ultrasound Probing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | |
Serious Adverse Events |
||
| Ultrasound Probing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Ultrasound Probing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Jae Kim, MD |
|---|---|
| Organization | University of California - San Diego |
| Phone | 619-543-3759 |
| neojae@ucsd.edu |
- NICU-TECH RM9L-RS