Difficult Intravenous Access
Conditions
Brief summary
The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (\<2years)
Detailed description
The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.
Interventions
DEVICEInfrared illumination
Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
1. Children(\<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital 2. ASA physical status 1,2 or 3
Exclusion criteria
1. Emergency procedures requiring anesthesia 2. ASA physical status 4 3. Patients with pre existing iv access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes | Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Attempts | When patient is in operating room and insertion of intravenous access line is performed | The number of attempts it takes for successful insertion of the intravenous access line |
| Time to Successful Insertion | When patient is in operating room and insertion of intravenous access line is performed | The time to successful insertion of the intravenous access line will be measured from the first time that the canula touches the skin to until successful iv access is established |
Countries
United States
Participant flow
Recruitment details
Potential subjects will be identified from the electronic operating room scheduling system (surginet) by reviewing the operative list schedule the day before or on the day of their scheduled surgical or diagnostic procedure.
Participants by arm
| Arm | Count |
|---|---|
| Infrared Vein Illumination Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device. | 79 |
| Standard Technique Standard vein location techniques will be used when inserting an intravenous access line | 80 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject withdrawn because research physician could not make it in time to place IV | 1 | 0 |
Baseline characteristics
| Characteristic | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| Age, Continuous | 13.11 months STANDARD_DEVIATION 6.19 | 12.42 months STANDARD_DEVIATION 6.44 | 12.76 months STANDARD_DEVIATION 6.31 |
| Anticipated IV access difficulty 0 | 0 participants | 5 participants | 5 participants |
| Anticipated IV access difficulty 1 | 14 participants | 9 participants | 23 participants |
| Anticipated IV access difficulty 2 | 22 participants | 19 participants | 41 participants |
| Anticipated IV access difficulty 3 | 23 participants | 26 participants | 49 participants |
| Anticipated IV access difficulty 4 | 11 participants | 11 participants | 22 participants |
| Anticipated IV access difficulty 5 | 9 participants | 9 participants | 18 participants |
| ASA physical Status 1 | 19 Participants | 21 Participants | 40 Participants |
| ASA physical Status 2 | 47 Participants | 43 Participants | 90 Participants |
| ASA physical Status 3 | 13 Participants | 16 Participants | 29 Participants |
| ASA physical Status 4 | 0 Participants | 0 Participants | 0 Participants |
| ASA physical Status 5 | 0 Participants | 0 Participants | 0 Participants |
| Prematurity no | 65 Participants | 68 Participants | 133 Participants |
| Prematurity yes | 13 Participants | 12 Participants | 25 Participants |
| Race/Ethnicity, Customized African American | 5 participants | 8 participants | 13 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Caucasian | 60 participants | 56 participants | 116 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 8 participants | 10 participants | 18 participants |
| Race/Ethnicity, Customized Mixed Race | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Unknown | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 79 Participants | 80 Participants | 159 Participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 74 Participants |
| Sex: Female, Male Male | 43 Participants | 42 Participants | 85 Participants |
| Skin Color Dark | 4 Participants | 4 Participants | 8 Participants |
| Skin Color Light | 60 Participants | 57 Participants | 117 Participants |
| Skin Color Medium | 15 Participants | 18 Participants | 33 Participants |
| Time without liquids | 6.93 hours STANDARD_DEVIATION 3.82 | 6.37 hours STANDARD_DEVIATION 3.72 | 6.66 hours STANDARD_DEVIATION 3.77 |
| Weight | 9.45 kilograms STANDARD_DEVIATION 2.32 | 9.13 kilograms STANDARD_DEVIATION 2.23 | 9.30 kilograms STANDARD_DEVIATION 2.28 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 80 |
| other Total, other adverse events | 0 / 79 | 0 / 80 |
| serious Total, serious adverse events | 0 / 79 | 0 / 80 |
Outcome results
Primary
Success Rate
Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline
Time frame: When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infrared Vein Illumination | Success Rate | 84.81 percentage of participants |
| Standard Technique | Success Rate | 90 percentage of participants |
p-value: 0.34Fisher Exact
Secondary
The Number of Attempts
The number of attempts it takes for successful insertion of the intravenous access line
Time frame: When patient is in operating room and insertion of intravenous access line is performed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infrared Vein Illumination | The Number of Attempts | 1.93 number of attempts | Standard Deviation 1.46 |
| Standard Technique | The Number of Attempts | 2.15 number of attempts | Standard Deviation 3.11 |
p-value: 0.4Jonckheere-Terpstra Test
Secondary
Time to Successful Insertion
The time to successful insertion of the intravenous access line will be measured from the first time that the canula touches the skin to until successful iv access is established
Time frame: When patient is in operating room and insertion of intravenous access line is performed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infrared Vein Illumination | Time to Successful Insertion | 149.39 seconds | Standard Deviation 354.04 |
| Standard Technique | Time to Successful Insertion | 136.92 seconds | Standard Deviation 179.79 |
p-value: 0.9Jonckheere-Terpstra Test