NCT02789046

Brief Summary

The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period. The main objective: the outcome of interest is defined as failure of cannulation on first attempt. The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

16 active sites

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

May 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 4, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

May 24, 2016

Last Update Submit

April 2, 2019

Conditions

Keywords

adultvascular accesspreoperative periodperipheral venous catheterization

Outcome Measures

Primary Outcomes (1)

  • failure intravenous placement on the first attempt

    during the hour before surgery

Secondary Outcomes (1)

  • risk factors associated with failure intravenous catheterization

    during the hour before surgery

Interventions

success or failure intravenous placement on first attempt and factors associated with failed intravenous catheterization

Eligibility Criteria

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

Patients undergoing peripheral intravenous placement just before a surgery will be enrolled. (the investigator does not assign specific interventions to the subjects of the study)

You may qualify if:

  • patients \>18 years old, undergoing peripheral IV placement just before a surgery in operating room

You may not qualify if:

  • patients who refused IV placement; pregnant woman; induction of anesthesia with sevoflurane without venous access in place

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Centre Hospitalier Sud Gironde

Lagon, France, France

Location

CHU Saint Pierre

Saint Pierre La Réunion, Ile de La Réunion, France

Location

Centre Hospitalier d'Agen

Agen, France

Location

Centre Médico-chirurgical Wallerstein

Arès, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, France

Location

Clinique Saint Augustin Bordeaux

Bordeaux, 33000, France

Location

Institut Bergonié

Bordeaux, 33000, France

Location

Centre hospitalier Universitaire de Bordeaux

Bordeaux, France

Location

Hôpital d'instruction des Armées Robert Picqué

Bordeaux, France

Location

Centre Hospitalier de Dax

Dax, France

Location

Centre Hospitalier d'Arcachon

La Teste-de-Buch, 33260, France

Location

Centre Hospitalier de Libourne

Libourne, France

Location

Centre Hospitalier de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Hospitalier de Pau

Pau, France

Location

Centre Hospitalier de Périgueux

Périgueux, France

Location

Centre Hospitalier de Tahiti

Tahiti, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 2, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 4, 2019

Record last verified: 2019-03

Locations