Neonates
Conditions
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.
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.
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.
Interventions
None listed
Sponsors
GE Healthcare
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
If participants health worsens prior to assignment they were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound Probing Ultrasound probing to guide catheter placement | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Ultrasound Probing |
|---|---|
| Age, Categorical <=18 years | 31 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 0.5 years STANDARD_DEVIATION 0.02 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
Time frame: 1 day (day of procedure)
Population: Study participants who have one or more catheters in place.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Observational Ultrasound | Participants That Fulfilled All Study Procedures. | 31 Participants |
Primary
Vessel Penetration of NICU-Tech RM9L-RS Probe
The algorithmic depth of vessel penetration will be collected.
Time frame: 1 day (day of procedure)
Population: Images were not adequate to visualize catheter penetration, or to obtain measurements.