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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02789046
Other study ID # CHUBXSAR32016-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date June 2018

Study information

Verified date March 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


Description:

Objectives:

To define a difficult intravenous access score in adult during the preoperative period Methods Multicenter, Observational prospective study

Patients:

patients >18 years old, undergoing peripheral IV placement just before a surgery in operating room excision criteria: pregnant woman, induction of anesthesia with sevoflurane, Predictor variables include: history of patient (age,BMI, Fitzpatrick skin type, cancer, ICU stay, burn, diabetes, kidney disease, anxiety of patient...) , operator experience characteristics( years since graduation, years of anesthesiology experience, IVs started per month), type of catheter and place of catheterization),and postcatheterization data (success on fist attempt yes or no, number of total attempts until success...)


Recruitment information / eligibility

Status Completed
Enrollment 3300
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms

  • Peripheral Venous Catheterization

Intervention

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

Locations

Country Name City State
France Centre Hospitalier d'Agen Agen
France Centre Médico-chirurgical Wallerstein Ares
France Centre Hospitalier de la Cote Basque Bayonne
France Centre hospitalier Universitaire de Bordeaux Bordeaux
France Clinique Saint Augustin Bordeaux Bordeaux
France Hôpital d'instruction des Armées Robert Picqué Bordeaux
France Institut Bergonié Bordeaux
France Centre Hospitalier de Dax Dax
France Centre Hospitalier d'Arcachon La teste de buch
France Centre Hospitalier Sud Gironde Lagon
France Centre Hospitalier de Libourne Libourne
France Centre Hospitalier de Mont de Marsan Mont de Marsan
France Centre Hospitalier de Pau Pau
France Centre Hospitalier de Périgueux Périgueux
France CHU Saint Pierre Saint Pierre La Réunion Ile De La Réunion
France Centre Hospitalier de Tahiti Tahiti

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary failure intravenous placement on the first attempt during the hour before surgery
Secondary risk factors associated with failure intravenous catheterization during the hour before surgery
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