NCT01602133

Brief Summary

Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

May 17, 2012

Last Update Submit

October 24, 2012

Conditions

Venous Puncture

Keywords

venous punctureseldinger techniqueultrasound guidance

Outcome Measures

Primary Outcomes (1)

  • length of use of the catheter measured in number of days

    seven days

Secondary Outcomes (1)

  • adverse event during the period of use of the catheter

    seven days

Study Arms (1)

one intervention arm

EXPERIMENTAL
Procedure: peripheral venous puncture

Interventions

peripheral venous puncturePROCEDURE

Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.

one intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients with need of an intravenous therapy on peripheral line
  • Unsuccessful attempts at establishing a peripheral intravenous line by nurse
  • Age over 18 YO
  • Written informed consent obtained

You may not qualify if:

  • pregnant woman
  • local contra-indication for venous puncture
  • unconscious patient
  • need of intravenous therapy requiring central line

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91 100, France

RECRUITING

Related Publications (1)

  • Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

    PMID: 36507736DERIVED

Study Officials

  • Pascal Meyer, MD

    Centre Hospitalier Sud Francilien- Corbeil- France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

pascal meyer, MD

CONTACT

pas.meyer@yahoo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2012

First Posted

May 18, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

FR(1)