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Images not adequate to visualize catheter penetration or obtain measurements
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: observational ultrasound | Collection of image data with the ultrasound probe. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jae Kim, MD | UCSD Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
If participants health worsens prior to assignment they were excluded from the study.
This is an observational study where recruitment took place in the Neonatal Intensive Care Unit. Enrollment period of June 2010 - November 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Probing | Ultrasound probing to guide catheter placement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects that underwent an ultrasound scan during the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Probing | Ultrasound probing to guide catheter placement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study participants who have one or more catheters in place. | Posted | Count of Participants | Participants | 1 day (day of procedure) |
|
|
1.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound Probing | Ultrasound probing to guide catheter placement | 0 |
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Enrollment was stopped early/terminated, study development stopped and no results were analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jae Kim, MD | University of California - San Diego | 619-543-3759 | neojae@ucsd.edu |
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| ID | Term |
|---|---|
| D018880 | Atrial Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Vessel Penetration of NICU-Tech RM9L-RS Probe | The algorithmic depth of vessel penetration will be collected. | Images were not adequate to visualize catheter penetration, or to obtain measurements. | Posted | 1 day (day of procedure) |
|
|
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |