Failure of First-attempt Insertion and Analysis of Practices Related to Peripheral Intravenous Catheters in the Emergency Department: (CATHIRU)

June 3, 2025 updated by: Poitiers University Hospital

Failure of First-attempt Insertion and Analysis of Practices Related to Peripheral Intravenous Catheters in the Emergency Department: A Prospective Observational Study by the French "Emergency Department Research Initiative" ("Initiatives de Recherche Aux Urgences" IRU) Network

Peripheral intravenous catheters (PIVCs) are essential for the management of hospitalised patients, particularly in emergency departments, where they are used to administer intravenous treatments to more than half of all patients. However, nearly 30% of insertion attempts fail on the first attempt, causing stress and pain for patients and delaying treatment. Despite their importance, PIVC insertion and management practices remain insufficiently standardised and studied, especially in the emergency setting. The CathIRU study aims to address these gaps by investigating the incidence of first-attempt insertion failure and analysing associated practices.

The primary objectives of the study are to estimate the incidence of first-attempt PIVC insertion failure in emergency departments and to identify predictive criteria for difficult vascular access. Secondary objectives include analysing PIVC insertion and management practices, assessing the incidence of unnecessary catheters placed in emergency settings, and evaluating the use of vein access techniques and alternative approaches in cases of failed insertion.

This is a prospective, multicentre observational epidemiological study. It will include 3,000 adult patients requiring a PIVC, recruited over two consecutive days in 70 centres within the IRU network. Data collection will include patient characteristics, insertion site, catheter specifications, insertion techniques, and clinical context.

Inclusion criteria comprise adult patients requiring a PIVC who have provided verbal consent for data collection. Patients with major life-threatening distress or those who had a PIVC inserted in a prehospital setting will be excluded. Data analysis will involve bivariate and multivariate logistic regression to identify risk factors associated with insertion failure and unnecessary catheters, with continuous and categorical data summarised using appropriate descriptive statistics.

The expected benefits of this study include improving PIVC insertion and management practices by enabling early identification of patients at risk of difficult vascular access, reducing complications linked to repeated punctures and delays in diagnostic and therapeutic care, and increasing awareness and training among healthcare professionals in best practices and technologies such as ultrasound guidance. In terms of societal impact, optimising PIVC management is expected to enhance patient care quality, reduce medical costs, and minimise medical waste.

The study is funded by the Société Française de Médecine d'Urgence (SFMU).

Study Overview

Study Type

Observational

Enrollment (Actual)

4312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Poitiers, France, 86021
        • CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients requiring a CVP in an emergency department can participate in the study

Description

Inclusion Criteria:

  • Adult over 18 years old
  • Requiring peripheral vascular access
  • Having provided oral consent for data collection

Exclusion Criteria:

  • Patient presenting with a state of major life-threatening distress, which may justify the placement of an intraosseous line and/or prevent data collection
  • Patient who received vascular access in the prehospital setting
  • Patient who has already participated in the study
  • Subject not covered by a social security scheme
  • Subjects under enhanced protection, namely persons deprived of liberty by a judicial or administrative decision, persons residing in a healthcare or social facility, adults under legal protection (guardianship or curatorship), and patients in emergency situations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort of patients with attempted vascular access insertion
All adult patients requiring a CVP in an emergency department can participate in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the prevalence of first-attempt PIVC insertion failure
Time Frame: 24 hours

The prevalence of first-attempt insertion failure will be defined as the number of patients for whom a functional PIVC could not be successfully placed during the first puncture attempt.

A functional PIVC is defined as one that allows the unrestricted injection of a solution or medication from an infusion line or a flushing syringe. It must be free from complications such as haematoma at the puncture site, extravasation, pain, or arterial reflux.

We estimate that 20% of patients will experience a first-attempt PIVC insertion failure.

24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyse practices related to the insertion and maintenance of PIVCs
Time Frame: 24 hours
24 hours
Identify the demographic criteria impacting vascular access and predicting failure of insertion at the first attempt
Time Frame: 24 hours
24 hours
Identify the demographic criteria of centers impacting the incidence of unnecessary catheters placed in emergency departments
Time Frame: 24 hours
24 hours
Estimate the percentage of patients presenting with criteria for Difficult Vascular Access
Time Frame: 24 hours
24 hours
Assess the association between first-attempt insertion failure and the presence of Difficult Vascular Access criteria
Time Frame: 24 hours
24 hours
Estimate the prevalence of unnecessary catheters placed in the emergency room
Time Frame: 24 hours
24 hours
Determine the frequency of use of different vein approach techniques
Time Frame: 24 hours
24 hours
Determine the frequency of use of alternative vascular access in the event of failure of installation
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Actual)

April 5, 2025

Study Completion (Actual)

April 6, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CATHIRU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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