NCT03555864

Brief Summary

Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index \> 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in obese patients (surgical and obstetric).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

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

Study Start

First participant enrolled

November 6, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

December 30, 2017

Last Update Submit

July 4, 2019

Conditions

Obesity, MorbidObstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (1)

  • success for second intravenous line using infra red

    number of attempts

    1 day

Secondary Outcomes (1)

  • time

    1 day

Study Arms (1)

Obese

Patients need two intravenous access with infra red

Device: infrared transluminescent device

Interventions

infrared transluminescent deviceDEVICE

use of infra red for venous access for second intravenous access

Obese

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that need second intravenous access for surgery or obstetric

You may qualify if:

  • \> 18 years
  • surgery that need double intravenous perfusion

You may not qualify if:

  • \< 18 years
  • body mass index\< 35
  • refusal
  • minor surgery that need only one intravenous access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, Gard, 30 000, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • jean-yves Lefrant, MD,PhD

    Centre Hospitalier Universitaire de Nīmes

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 30, 2017

First Posted

June 14, 2018

Study Start

November 6, 2017

Primary Completion

November 30, 2018

Study Completion

July 4, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)