Saphenous Vein CannulationNCT01924975

Saphenous Vein Cannulation in Infants and Small Children

A study testing Saphenous vein cannulation, ultrasound with a linear transducer (L15-7io) and A 22 or 24 G intravenous catheter in people with Saphenous Vein Cannulation, run by Satoshi Hanada at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages Up to 4 years
Conditions the study is for: Saphenous Vein Cannulation
What is being tested?: Saphenous vein cannulation, ultrasound with a linear transducer (L15-7io) and A 22 or 24 G intravenous catheter
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

Pediatric patient undergoing scheduled surgery which requires venous cannulation.
Term neonates and children < 4 years old weighing >/= 3 kg

Who cannot join

Patient with visible saphenous vein
Patient with no detectable saphenous vein under ultrasound
Patient with a skin wound or infection around puncture site
Patient with recent venous puncture at the puncture site (less than 1 month)
Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
Patient with any emergency surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Ultrasound-image Guided Versus Traditional Landmark Technique for Saphenous Vein Cannulation in Infants and Small Children

Conditions: Saphenous Vein Cannulation
Being tested: Saphenous vein cannulation, ultrasound with a linear transducer (L15-7io), A 22 or 24 G intravenous catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Saphenous vein cannulationProcedure or surgery
Intravenous cannulation to saphenous vein
ultrasound with a linear transducer (L15-7io)Device
Portable, bed-side ultrasound to detect saphenous vein
A 22 or 24 G intravenous catheterDevice

Study groups in NCT01924975
Study group	Role	What they receive
Landmark group	Active comparator	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. Receives: Procedure: Saphenous vein cannulation; Device: A 22 or 24 G intravenous catheter
Ultrasound group	Active comparator	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. Receives: Procedure: Saphenous vein cannulation; Device: ultrasound with a linear transducer (L15-7io); Device: A 22 or 24 G intravenous catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation
Measured: 10 minutes

Secondary outcomes (2)

Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.
Measured: 10 minutes
Time Required for Overall Successful Venous Cannulation.
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jul 2014

First posted19 Aug 2013 (estimated)
Study startJul 2013
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Saphenous Vein CannulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01924975
Sponsor's protocol ID: V-line study
Status last verified: Dec 2017
First submitted: 14 Aug 2013
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Triffterer L, Marhofer P, Willschke H, Machata AM, Reichel G, Benkoe T, Kettner SC. Ultrasound-guided cannulation of the great saphenous vein at the ankle in infants. Br J Anaesth. 2012 Feb;108(2):290-4. doi: 10.1093/bja/aer334. Epub 2011 Oct 27.
PubMed 22037223
Riera A, Langhan M, Northrup V, Santucci K, Chen L. Remember the saphenous: ultrasound evaluation and intravenous site selection of peripheral veins in young children. Pediatr Emerg Care. 2011 Dec;27(12):1121-5. doi: 10.1097/PEC.0b013e31823ab926.
PubMed 22134232
Joshi M, Wilson G, Engelhardt T. Comparison of landmark technique and ultrasound guidance for localisation of long saphenous vein in infants and children. Emerg Med J. 2010 Jun;27(6):443-5. doi: 10.1136/emj.2008.069310.
PubMed 20562139

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound-image Guided Versus Traditional Landmark Technique for Saphenous Vein Cannulation in Infants and Small Children
ClinicalTrials.gov ID: NCT01924975
Acronym / sponsor ID: V-line study
Conditions: Saphenous Vein Cannulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Satoshi HanadaUniversity, hospital or other
Study start: Jul 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 19 Aug 2013 (estimated)
Results: Posted 4 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Landmark group	Active comparator	Procedure: Saphenous vein cannulation, Device: A 22 or 24 G intravenous catheterAn 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.
Ultrasound group	Active comparator	Procedure: Saphenous vein cannulation, Device: ultrasound with a linear transducer (L15-7io), Device: A 22 or 24 G intravenous catheterAn 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.

Who may qualify

Ages: Up to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Pediatric patient undergoing scheduled surgery which requires venous cannulation.
Term neonates and children < 4 years old weighing >/= 3 kg

Key exclusion criteria (6 listed)

Patient with visible saphenous vein
Patient with no detectable saphenous vein under ultrasound
Patient with a skin wound or infection around puncture site
Patient with recent venous puncture at the puncture site (less than 1 month)
Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Saphenous vein cannulationIntravenous cannulation to saphenous vein	Procedure or surgery	Landmark group, Ultrasound group
ultrasound with a linear transducer (L15-7io)Portable, bed-side ultrasound to detect saphenous vein	Device	Ultrasound group
A 22 or 24 G intravenous catheter	Device	Landmark group, Ultrasound group

Primary outcome

Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation
Time frame: 10 minutes

2 secondary outcomes

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
Time Required for Overall Successful Venous Cannulation.
Time frame: 10 minutes

Results and safety

Results posted to the registry on 4 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Landmark Group	51	51
Ultrasound Group	51	51

Primary outcome: Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation

Time frame: 10 minutes. Number. Unit: percent of participants

Measure	Landmark Group n = 51	Ultrasound Group n = 51
Value	51.0	90.2

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Landmark Group	0 of 51 (0%)	0 of 51 (0%)	Not reported
Ultrasound Group	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22037223Triffterer L, Marhofer P, Willschke H, Machata AM, Reichel G, Benkoe T, Kettner SC. Ultrasound-guided cannulation of the great saphenous vein at the ankle in infants. Br J Anaesth. 2012 Feb;108(2):290-4. doi: 10.1093/bja/aer334. Epub 2011 Oct 27.
Background: PubMed 22134232Riera A, Langhan M, Northrup V, Santucci K, Chen L. Remember the saphenous: ultrasound evaluation and intravenous site selection of peripheral veins in young children. Pediatr Emerg Care. 2011 Dec;27(12):1121-5. doi: 10.1097/PEC.0b013e31823ab926.
Background: PubMed 20562139Joshi M, Wilson G, Engelhardt T. Comparison of landmark technique and ultrasound guidance for localisation of long saphenous vein in infants and children. Emerg Med J. 2010 Jun;27(6):443-5. doi: 10.1136/emj.2008.069310.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Satoshi Hanada, MD principal investigator

University of Iowa Hospitals & Clinics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01924975, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.