Trial Outcomes & Findings for A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique (NCT NCT01042613)

Results Overview

This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

146 participants

Primary outcome timeframe

At cannulation

Results posted on

2011-12-07

Participant Flow

148 total patients were recruited at single institution (SJCRH) study between Jan 13, 2010, and March 03, 2011.

148 total patients were enrolled on the study. The report is based on results for 146 patients. Two patients were excluded from this study. One patient was excluded due to MD's decision and the other patient was deemed to be inevaluable after study enrollment (cannula gauge other than 22 were used).

Participant milestones

Participant milestones
Measure	ACVein Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	Standard (standard technique of insertion of the intravenous cannula)
Overall Study STARTED	72	74
Overall Study COMPLETED	72	74
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACVein n=72 Participants Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	Standard n=74 Participants (standard technique of insertion of the intravenous cannula)	Total n=146 Participants Total of all reporting groups
Age Continuous	5.72 years STANDARD_DEVIATION 3.72 • n=5 Participants	5.37 years STANDARD_DEVIATION 3.88 • n=7 Participants	5.54 years STANDARD_DEVIATION 3.79 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	43 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: At cannulation

Population: Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.

This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.

Outcome measures

Outcome measures
Measure	ACVein n=72 Participants Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	Standard n=74 Participants (standard technique of insertion of the intravenous cannula)
First Attempt Success Rate of Cannulation Successful first attempt	54 Participants	54 Participants
First Attempt Success Rate of Cannulation Unsuccessful first attempt	18 Participants	20 Participants

SECONDARY outcome

Timeframe: At cannulation

Population: Of the 146 patients, two patients were excluded due to missing time records.

To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique

Outcome measures

Outcome measures
Measure	ACVein n=71 Participants Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	Standard n=73 Participants (standard technique of insertion of the intravenous cannula)
Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).	1.48 Minutes Standard Deviation .97	1.26 Minutes Standard Deviation .84

SECONDARY outcome

Timeframe: At cannulation

To assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique

Outcome measures

Outcome measures
Measure	ACVein n=72 Participants Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	Standard n=74 Participants (standard technique of insertion of the intravenous cannula)
Number of Skin Punctures	1.33 Skin punctures Standard Deviation .75	1.26 Skin punctures Standard Deviation .62

Adverse Events

ACVein

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard

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

Luis Trujillo Huaccho, MD

St. Jude Children's Research Hospital

Phone: 1-866-278-5833

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place