Trial Outcomes & Findings for NICU-TECH RM9L-RS Probe ME Feasibility Study (NCT NCT01181596)
NCT ID: NCT01181596
Last Updated: 2019-08-06
Results Overview
Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.
TERMINATED
31 participants
1 day (day of procedure)
2019-08-06
Participant Flow
This is an observational study where recruitment took place in the Neonatal Intensive Care Unit. Enrollment period of June 2010 - November 2011.
If participants health worsens prior to assignment they were excluded from the study.
Participant milestones
| Measure |
Ultrasound Probing
Ultrasound probing to guide catheter placement
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NICU-TECH RM9L-RS Probe ME Feasibility Study
Baseline characteristics by cohort
| Measure |
Ultrasound Probing
n=31 Participants
Ultrasound probing to guide catheter placement
|
|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
0.5 years
STANDARD_DEVIATION .02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (day of procedure)Population: Study participants who have one or more catheters in place.
Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.
Outcome measures
| Measure |
Arm 1: Observational Ultrasound
n=31 Participants
Collection of image data with the ultrasound probe.
|
|---|---|
|
Participants That Fulfilled All Study Procedures.
|
31 Participants
|
PRIMARY outcome
Timeframe: 1 day (day of procedure)Population: Images were not adequate to visualize catheter penetration, or to obtain measurements.
The algorithmic depth of vessel penetration will be collected.
Outcome measures
Outcome data not reported
Adverse Events
Ultrasound Probing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60