Cannulation
Conditions
Keywords
AccuVein AV300 device;, Intravenous cannulation
Brief 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.
Detailed description
Patients agreeing to participate in this study will be randomized to one of two groups for intravenous access. One group will use the standard cannulation method and the other group will use the new FDA approved AccuVein AV300 device for cannulation. After pre-anesthetic evaluation, the research participant will be brought to the operating room or magnetic resonance imaging (MRI) Suite and standard monitoring will be applied (EKG, SpO2, BP) if tolerated. Anesthesia will be induced via a face mask with sevoflurane in 100% O2. When the supervising anesthesiologist deems it appropriate, attempt at cannulation will begin. A tourniquet will be applied. A 22-gauge cannula will be used. Randomization will take place before the patient is taken back to the Operating Room or MRI Suite. If the research participant has been randomized to the standard treatment group then cannulation will be attempted in the standard manner. If the research participant has been randomized to the AV300 device group then intravenous cannulation will be attempted using the AV300 device following the manufacturer's instructions. A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made. Only the study coordinator will know which randomization group the patient has been assigned. Once the anesthesiologist has determined a potential IV access site, s/he will be informed to which group the patient was assigned. If the parent/guardian requests, s/he will be told after the procedure to which group the child was randomized.
Interventions
PROCEDURECannulation using Accuvein device
If the research participant has been randomized to the AV300 device group A, then intravenous cannulation will be attempted using the AV300 device following manufacturer's instructions by four anesthesiologists.
PROCEDUREStandard Cannulation method
If the research participant has been randomized to the standard treatment group B then cannulation will be attempted in the standard manner. A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Infants and children under 18 years of age. 2. American Society of Anesthesiologist (ASA) Physical Status I, II or III. 3. Patients undergoing elective surgery,examination under anesthesia,or MRI who do not have existing intravenous access. 4. Able to understand English. 5. Parent/guardian willing to sign consent.
Exclusion criteria
1. Existing intravenous access. 2. Malformations or infections at the potential site of insertion. 3. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. 4. Need for emergency surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Attempt Success Rate of Cannulation | At cannulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). | At cannulation | 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 |
| Number of Skin Punctures | 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 |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| ACVein Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion) | 72 |
| Standard (standard technique of insertion of the intravenous cannula) | 74 |
| Total | 146 |
Baseline characteristics
| Characteristic | Standard | Total | ACVein |
|---|---|---|---|
| Age Continuous | 5.37 years STANDARD_DEVIATION 3.88 | 5.54 years STANDARD_DEVIATION 3.79 | 5.72 years STANDARD_DEVIATION 3.72 |
| Sex: Female, Male Female | 43 Participants | 78 Participants | 35 Participants |
| Sex: Female, Male Male | 31 Participants | 68 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 72 | 0 / 74 |
| serious Total, serious adverse events | 0 / 72 | 0 / 74 |
Outcome results
Primary
First Attempt Success Rate of Cannulation
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
Population: Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACVein | First Attempt Success Rate of Cannulation | Successful first attempt | 54 Participants |
| ACVein | First Attempt Success Rate of Cannulation | Unsuccessful first attempt | 18 Participants |
| Standard | First Attempt Success Rate of Cannulation | Successful first attempt | 54 Participants |
| Standard | First Attempt Success Rate of Cannulation | Unsuccessful first attempt | 20 Participants |
p-value: 0.851Fisher Exact
Secondary
Number of Skin Punctures
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACVein | Number of Skin Punctures | 1.33 Skin punctures | Standard Deviation 0.75 |
| Standard | Number of Skin Punctures | 1.26 Skin punctures | Standard Deviation 0.62 |
p-value: 0.8Wilcoxon (Mann-Whitney)
Secondary
Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).
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
Population: Of the 146 patients, two patients were excluded due to missing time records.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACVein | Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). | 1.48 Minutes | Standard Deviation 0.97 |
| Standard | Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). | 1.26 Minutes | Standard Deviation 0.84 |
p-value: 0.105Wilcoxon (Mann-Whitney)