Intravenous Access
Conditions
Brief summary
The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.
Interventions
DEVICESingle Use Vein Entry Indicator Device
Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient age \< 18 years old. * Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access. * Written informed consent/ assent from the patient or legal guardian.
Exclusion criteria
\- Patient age \> 18 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With IV Access at First Attempt | Baseline | Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard IV Insertion Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion | 84 |
| SU-VEID Assisted IV Insertion Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device
Single Use Vein Entry Indicator Device: Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation. | 85 |
| Total | 169 |
Baseline characteristics
| Characteristic | SU-VEID Assisted IV Insertion | Total | Standard IV Insertion |
|---|---|---|---|
| Age, Continuous | 5.35 years STANDARD_DEVIATION 4.19 | 5.33 years STANDARD_DEVIATION 4.086 | 5.31 years STANDARD_DEVIATION 3.99 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 85 participants | 169 participants | 84 participants |
| Sex: Female, Male Female | 36 Participants | 72 Participants | 36 Participants |
| Sex: Female, Male Male | 49 Participants | 97 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 85 |
| other Total, other adverse events | 0 / 84 | 0 / 85 |
| serious Total, serious adverse events | 0 / 84 | 0 / 85 |
Outcome results
Primary
Percentage of Participants With IV Access at First Attempt
Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard IV Insertion | Percentage of Participants With IV Access at First Attempt | 70.2 percentage of participants |
| SU-VEID Assisted IV Insertion | Percentage of Participants With IV Access at First Attempt | 67.1 percentage of participants |