Saphenous Vein Cannulation
Conditions
Brief summary
The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).
Interventions
PROCEDURESaphenous vein cannulation
Intravenous cannulation to saphenous vein
DEVICEultrasound with a linear transducer (L15-7io)
Portable, bed-side ultrasound to detect saphenous vein
DEVICEA 22 or 24 G intravenous catheter
Sponsors
Satoshi Hanada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patient undergoing scheduled surgery which requires venous cannulation. 2. Term neonates and children \< 4 years old weighing \>/= 3 kg
Exclusion criteria
1. Patient with visible saphenous vein 2. Patient with no detectable saphenous vein under ultrasound 3. Patient with a skin wound or infection around puncture site 4. Patient with recent venous puncture at the puncture site (less than 1 month) 5. Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound. 6. Patient with any emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation | 10 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. | 10 minutes |
| Time Required for Overall Successful Venous Cannulation. | 10 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Landmark Group An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
A 22 or 24 G intravenous catheter | 51 |
| Ultrasound Group An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein
A 22 or 24 G intravenous catheter | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | Landmark Group | Ultrasound Group | Total |
|---|---|---|---|
| Age, Continuous | 12 months | 8 months | 11 months |
| Sex: Female, Male Female | 24 Participants | 16 Participants | 40 Participants |
| Sex: Female, Male Male | 27 Participants | 35 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation
Time frame: 10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Landmark Group | Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation | 51.0 percent of participants |
| Ultrasound Group | Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation | 90.2 percent of participants |
Secondary
Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.
Time frame: 10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Landmark Group | Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. | 62.8 percent of participants |
| Ultrasound Group | Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. | 92.2 percent of participants |
Secondary
Time Required for Overall Successful Venous Cannulation.
Time frame: 10 minutes
Population: Includes only those participants for which successful cannulation was achieved.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Landmark Group | Time Required for Overall Successful Venous Cannulation. | 235 Seconds |
| Ultrasound Group | Time Required for Overall Successful Venous Cannulation. | 151 Seconds |