NCT02285712

Brief Summary

Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure. For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections. The use of ultrasound has gained increasing popularity particularly for obtaining central venous access. We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

November 5, 2014

Last Update Submit

February 28, 2017

Conditions

Keywords

Peripheral venous catheterultrasoundnurseIntensive Care Units

Outcome Measures

Primary Outcomes (1)

  • number of peripheral venous catheterization attempts

    Each day, only 3 attempts are allowed

    up to day 2

Secondary Outcomes (9)

  • Number of central lines removed

    intraoperative

  • central venous catheter dwell time

    intraoperative

  • peripheral venous catheter dwell time

    intraoperative

  • number of central line catheter related infection

    intraoperative

  • number of central line catheter related colonization

    intraoperative

  • +4 more secondary outcomes

Study Arms (2)

Classical method of peripheral venous catheterization

NO INTERVENTION

Classical method will be applied only on arm and forearm.

Ultrasound guided peripheral venous catheterization

EXPERIMENTAL

Nurse will use a vascular ultrasound system to orient the catheter toward the peripheral vein. Ultrasound method will be applied only on arm and forearm.

Device: Vascular ultrasound system

Interventions

Ultrasound guided peripheral venous catheterization

Eligibility Criteria

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

You may qualify if:

  • patient admitted in ICU
  • patient not able to express his opposition
  • central venous access that need to be removed
  • need for a peripheral venous access
  • no clinical instability
  • no visible superficial vein due to: BMI\> 30, fluid overload, previous history of IV drug abuse, previous history of chemotherapy ,

You may not qualify if:

  • patient \< 18 yo
  • pregnancy
  • patient under protective supervision
  • need for a central venous access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy - Service de Réanimation Médicale Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.

Study Officials

  • Antoine Kimmoun, M.D

    Intensive care unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations