Trial Outcomes & Findings for Saphenous Vein Cannulation in Infants and Small Children (NCT NCT01924975)
NCT ID: NCT01924975
Last Updated: 2018-01-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
10 minutes
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saphenous Vein Cannulation in Infants and Small Children
Baseline characteristics by cohort
| Measure |
Landmark Group
n=51 Participants
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
|
Ultrasound Group
n=51 Participants
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
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12 months
n=5 Participants
|
8 months
n=7 Participants
|
11 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutesOutcome measures
| Measure |
Landmark Group
n=51 Participants
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
|
Ultrasound Group
n=51 Participants
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
|
|---|---|---|
|
Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation
|
51.0 percent of participants
|
90.2 percent of participants
|
SECONDARY outcome
Timeframe: 10 minutesOutcome measures
| Measure |
Landmark Group
n=51 Participants
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
|
Ultrasound Group
n=51 Participants
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
|
|---|---|---|
|
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
|
92.2 percent of participants
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: Includes only those participants for which successful cannulation was achieved.
Outcome measures
| Measure |
Landmark Group
n=32 Participants
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
|
Ultrasound Group
n=47 Participants
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
|
|---|---|---|
|
Time Required for Overall Successful Venous Cannulation.
|
235 Seconds
Interval 179.0 to 300.0
|
151 Seconds
Interval 112.0 to 246.0
|
Adverse Events
Landmark Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Satoshi Hanada/Clinical Assistant Professor
University of Iowa Hopspital & Clinics
Phone: 3193561219
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place