Procedural Complication
Conditions
Brief summary
Background: 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. Objectives: To assess the effectiveness of the AV300 device over the standard technique in increasing the first-time success rate (SR) for pediatric patients who needed IV cannulation. Methods: This was a prospective cross study of patients aged 0-18 years scheduled for surgery or examination under anesthesia but without having an existing IV access and after providing consent form. Patients were randomized into two groups; cannulation with AV300 or standard insertion performed by experienced pediatric anesthesiologists and residents under training.
Detailed description
Patients who fulfilled the inclusion criteria and provided informed consent were assigned to one of two groups using a randomization program that assigned research participants into group A (AccuVein AV300 assisted intravenous catheter insertion) or group B (standard technique of insertion of the intravenous cannula). After pre-anesthetic evaluation, the research participant was brought to the operating room and standard monitoring were applied (EKG, SpO2, BP) if tolerated. Anesthesia was induced via face mask with sevoflurane in 100% O2. The anesthesiologist and resident decided on a site believed to be the best for cannulation and on the size of the venous cannula as 22g or 24g. When the supervising anesthesiologist deemed it appropriate, the venous cannulation was attempted, according to the randomization groups, either with the AccuVein device (group A) or blindly (group B). A rating of the vein attempted as either difficult or easy was established by the attending anesthesiologist.
Interventions
DEVICEAccuVein 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
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients less than 18 years of age, American Society of Anesthesiologist Physical Status (ASA) status I, II or III, undergoing elective surgery or examination under anesthesia, which did not have existing intravenous access.
Exclusion criteria
* Existing intravenous access, malformations or infections at the potential site of insertion, need for emergency surgery, and inability or unwillingness of parent or legal guardian to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method | Beginning of venous Cannulation until end of Cannulation, average of 1 min |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 92 |
| Standard Insertion Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein. | 92 |
| Total | 184 |
Baseline characteristics
| Characteristic | Standard Insertion | Total | Cannulation With AccuVein AV 300 |
|---|---|---|---|
| Age, Categorical <=18 years | 92 Participants | 184 Participants | 92 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.3 years STANDARD_DEVIATION 3.7 | 4.3 years STANDARD_DEVIATION 3.7 | 5.4 years STANDARD_DEVIATION 3.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Lebanon | 92 Participants | 184 Participants | 92 Participants |
| Sex: Female, Male Female | 58 Participants | 115 Participants | 57 Participants |
| Sex: Female, Male Male | 34 Participants | 69 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 92 | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 | 0 / 92 |
Outcome results
Primary
First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method
Time frame: Beginning of venous Cannulation until end of Cannulation, average of 1 min
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cannulation With AccuVein AV 300 | First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method | 92 Participants |
| Standard Insertion | First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method | 92 Participants |