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A Comparison of the First Attempt Success Rate of Cannulation Between the Accuvein Apparatus and Standard Technique

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ClinicalTrials.gov Identifier: NCT03462745
Recruitment Status : Completed
First Posted : March 13, 2018
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Roland Kaddoum, American University of Beirut Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Procedural Complication
Intervention Device: AccuVein AV 300
Enrollment 184
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cannulation With AccuVein AV 300 Standard Insertion
Hide Arm/Group Description

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

Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
Period Title: Overall Study
Started 92 92
Completed 92 92
Not Completed 0 0
Arm/Group Title Cannulation With AccuVein AV 300 Standard Insertion Total
Hide Arm/Group Description

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

Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein. Total of all reporting groups
Overall Number of Baseline Participants 92 92 184
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 92 participants 184 participants
<=18 years
92
 100.0%
92
 100.0%
184
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 92 participants 184 participants
5.4  (3.2) 4.3  (3.7) 4.3  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 92 participants 184 participants
Female
57
  62.0%
58
  63.0%
115
  62.5%
Male
35
  38.0%
34
  37.0%
69
  37.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Lebanon Number Analyzed 92 participants 92 participants 184 participants
92
 100.0%
92
 100.0%
184
 100.0%
1.Primary Outcome
Title First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method
Hide Description [Not Specified]
Time Frame Beginning of venous Cannulation until end of Cannulation, average of 1 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannulation With AccuVein AV 300 Standard Insertion
Hide Arm/Group Description:

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

Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
Overall Number of Participants Analyzed 92 92
Measure Type: Count of Participants
Unit of Measure: Participants
92
 100.0%
92
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cannulation With AccuVein AV 300 Standard Insertion
Hide Arm/Group Description

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

No adverse events reported.

Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.

No adverse events reported.

All-Cause Mortality
Cannulation With AccuVein AV 300 Standard Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cannulation With AccuVein AV 300 Standard Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/92 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cannulation With AccuVein AV 300 Standard Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/92 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Roland Kaddoum
Organization: American University of Beirut Medical Center
Phone: 01350000 ext 6704
Responsible Party: Roland Kaddoum, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03462745     History of Changes
Other Study ID Numbers: ANES.RK.01
First Submitted: February 28, 2018
First Posted: March 13, 2018
Results First Submitted: April 19, 2018
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019