N/A
N=146
A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique
Cannulation
Bottom Line
View on ClinicalTrials.gov: NCT01042613 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: First Attempt Success Rate of Cannulation — 54; 54; 18; 20 Participants — p=.851
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cannulation using Accuvein device (Procedure); Standard Cannulation method (Procedure)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Attempt Success Rate of Cannulation |
54; 54; 18; 20 | .851 |
| SECONDARY Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). |
1.48; 1.26 | .105 |
| SECONDARY Number of Skin Punctures |
1.33; 1.26 | .8 |
Summary
1. 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.
2. This study will assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.
3. This study will 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.
Eligibility Criteria
Inclusion Criteria
- Infants and children under 18 years of age.
- American Society of Anesthesiologist (ASA) Physical Status I, II or III.
- Patients undergoing elective surgery, examination under anesthesia,or MRI who do not have existing intravenous access.
- Able to understand English.
- Parent/guardian willing to sign consent.
Exclusion Criteria
- Existing intravenous access.
- Malformations or infections at the potential site of insertion.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Need for emergency surgery.
Data sourced from ClinicalTrials.gov (NCT01042613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.