Trial Outcomes & Findings for A Comparison of the First Attempt Success Rate of Cannulation Between the Accuvein Apparatus and Standard Technique (NCT NCT03462745)

NCT ID: NCT03462745

Last Updated: 2019-02-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 184 participants
• Primary outcome timeframe: Beginning of venous Cannulation until end of Cannulation, average of 1 min
• Results posted on: 2019-02-26

Participant Flow

Participant milestones

Measure	Cannulation With AccuVein AV 300 The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface. AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the first-time success rate (SR) for pediatric patients who needed IV cannulation	Standard Insertion Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
Overall Study STARTED	92	92
Overall Study COMPLETED	92	92
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cannulation With AccuVein AV 300 n=92 Participants The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface. AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the first-time success rate (SR) for pediatric patients who needed IV cannulation	Standard Insertion n=92 Participants Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.	Total n=184 Participants Total of all reporting groups
Age, Categorical <=18 years	92 Participants n=92 Participants	92 Participants n=92 Participants	184 Participants n=184 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=92 Participants	0 Participants n=92 Participants	0 Participants n=184 Participants
Age, Categorical >=65 years	0 Participants n=92 Participants	0 Participants n=92 Participants	0 Participants n=184 Participants
Age, Continuous	5.4 years STANDARD_DEVIATION 3.2 • n=92 Participants	4.3 years STANDARD_DEVIATION 3.7 • n=92 Participants	4.3 years STANDARD_DEVIATION 3.7 • n=184 Participants
Sex: Female, Male Female	57 Participants n=92 Participants	58 Participants n=92 Participants	115 Participants n=184 Participants
Sex: Female, Male Male	35 Participants n=92 Participants	34 Participants n=92 Participants	69 Participants n=184 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Lebanon	92 Participants n=92 Participants	92 Participants n=92 Participants	184 Participants n=184 Participants

PRIMARY outcome

Timeframe: Beginning of venous Cannulation until end of Cannulation, average of 1 min

Outcome measures

Measure	Cannulation With AccuVein AV 300 n=92 Participants The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface. AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the first-time success rate (SR) for pediatric patients who needed IV cannulation	Standard Insertion n=92 Participants Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method	92 Participants	92 Participants

Adverse Events

Cannulation With AccuVein AV 300

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roland Kaddoum

American University of Beirut Medical Center

Phone: 01350000

Email: rk16@aub.edu.lb

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place