NCT03139045

Brief Summary

Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2018

Typical duration for phase_3

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

April 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

April 27, 2017

Last Update Submit

January 17, 2023

Conditions

VenipunctureGeriatric

Outcome Measures

Primary Outcomes (1)

  • Quantification of the number of attempts to place the venous catheter for venipuncture

    3 days

Study Arms (2)

Venous puncture using VVV at the beginning of the procedure

ACTIVE COMPARATOR
Biological: Venous puncture in elderly patients

Venous puncture without VVV

ACTIVE COMPARATOR
Biological: Venous puncture in elderly patients

Interventions

Venous puncture in elderly patientsBIOLOGICAL

Venous puncture in elderly patients

Venous puncture using VVV at the beginning of the procedureVenous puncture without VVV

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient aged 75 years and over
  • Patient hospitalized in a department of acute geriatrics, whose venipuncture was prescribed

You may not qualify if:

  • Patient not affiliated to a social security scheme
  • Patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 3, 2017

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2021

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)