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

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ClinicalTrials.gov Identifier: NCT01042613
Recruitment Status : Completed
First Posted : January 5, 2010
Results First Posted : December 7, 2011
Last Update Posted : December 7, 2011
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Cannulation
Interventions Procedure: Cannulation using Accuvein device
Procedure: Standard Cannulation method
Enrollment 146
Recruitment Details 148 total patients were recruited at single institution (SJCRH) study between Jan 13, 2010, and March 03, 2011.
Pre-assignment Details 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).
Arm/Group Title ACVein Standard
Hide Arm/Group Description Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion) (standard technique of insertion of the intravenous cannula)
Period Title: Overall Study
Started 72 74
Completed 72 74
Not Completed 0 0
Arm/Group Title ACVein Standard Total
Hide Arm/Group Description Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion) (standard technique of insertion of the intravenous cannula) Total of all reporting groups
Overall Number of Baseline Participants 72 74 146
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 74 participants 146 participants
5.72  (3.72) 5.37  (3.88) 5.54  (3.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 146 participants
Female
35
  48.6%
43
  58.1%
78
  53.4%
Male
37
  51.4%
31
  41.9%
68
  46.6%
1.Primary Outcome
Title First Attempt Success Rate of Cannulation
Hide Description 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.
Time Frame At cannulation
Hide Outcome Measure Data
Hide Analysis Population Description
Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.
Arm/Group Title ACVein Standard
Hide Arm/Group Description:
Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
(standard technique of insertion of the intravenous cannula)
Overall Number of Participants Analyzed 72 74
Measure Type: Number
Unit of Measure: Participants
Successful first attempt 54 54
Unsuccessful first attempt 18 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACVein, Standard
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .851
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of the Binomial Proportions
Estimated Value .02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).
Hide Description 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
Time Frame At cannulation
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 146 patients, two patients were excluded due to missing time records.
Arm/Group Title ACVein Standard
Hide Arm/Group Description:
Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
(standard technique of insertion of the intravenous cannula)
Overall Number of Participants Analyzed 71 73
Mean (Standard Deviation)
Unit of Measure: Minutes
1.48  (.97) 1.26  (.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACVein, Standard
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .105
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .22
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Skin Punctures
Hide Description 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
Time Frame At cannulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACVein Standard
Hide Arm/Group Description:
Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
(standard technique of insertion of the intravenous cannula)
Overall Number of Participants Analyzed 72 74
Mean (Standard Deviation)
Unit of Measure: Skin punctures
1.33  (.75) 1.26  (.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACVein, Standard
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .8
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .07
Estimation Comments [Not Specified]
Time Frame 10 minutes per patient
Adverse Event Reporting Description Enrollment was from January, 2010 through March, 2011. Patients were off study at completion of cannulation.
 
Arm/Group Title ACVein Standard
Hide Arm/Group Description Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion) (standard technique of insertion of the intravenous cannula)
All-Cause Mortality
ACVein Standard
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ACVein Standard
Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/74 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACVein Standard
Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/74 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Luis Trujillo Huaccho, MD
Organization: St. Jude Children's Research Hospital
Phone: 1-866-278-5833
EMail: info@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01042613    
Other Study ID Numbers: ACVEIN
First Submitted: January 4, 2010
First Posted: January 5, 2010
Results First Submitted: September 9, 2011
Results First Posted: December 7, 2011
Last Update Posted: December 7, 2011