Trial Outcomes & Findings for A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children (NCT NCT05204082)

Results Overview

Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

169 participants

Primary outcome timeframe

Baseline

Results posted on

2024-05-23

Participant milestones
Measure	Standard IV Insertion Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion	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.
Overall Study STARTED	84	85
Overall Study COMPLETED	84	85
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Standard IV Insertion n=84 Participants Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion	SU-VEID Assisted IV Insertion n=85 Participants 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.	Total n=169 Participants Total of all reporting groups
Age, Continuous	5.31 years STANDARD_DEVIATION 3.99 • n=84 Participants	5.35 years STANDARD_DEVIATION 4.19 • n=85 Participants	5.33 years STANDARD_DEVIATION 4.086 • n=169 Participants
Sex: Female, Male Female	36 Participants n=84 Participants	36 Participants n=85 Participants	72 Participants n=169 Participants
Sex: Female, Male Male	48 Participants n=84 Participants	49 Participants n=85 Participants	97 Participants n=169 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	84 participants n=84 Participants	85 participants n=85 Participants	169 participants n=169 Participants

Timeframe: 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

Outcome measures
Measure	Standard IV Insertion n=84 Participants Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion	SU-VEID Assisted IV Insertion n=85 Participants 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.
Percentage of Participants With IV Access at First Attempt	70.2 percentage of participants	67.1 percentage of participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Mayo Clinic

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