NCT06851585

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 3, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2025

Completed
Last Updated

June 4, 2025

Status Verified

March 1, 2025

Enrollment Period

2 days

First QC Date

February 24, 2025

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Estimate the prevalence of first-attempt PIVC insertion failure

    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 Outcomes (8)

  • Analyse practices related to the insertion and maintenance of PIVCs

    24 hours

  • Estimate the percentage of patients presenting with criteria for Difficult Vascular Access

    24 hours

  • Assess the association between first-attempt insertion failure and the presence of Difficult Vascular Access criteria

    24 hours

  • Identify the demographic criteria impacting vascular access and predicting failure of insertion at the first attempt

    24 hours

  • Estimate the prevalence of unnecessary catheters placed in the emergency room

    24 hours

  • +3 more secondary outcomes

Study Arms (1)

Cohort of patients with attempted vascular access insertion

Device: CathIRU Cohort

Interventions

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

Cohort of patients with attempted vascular access insertion

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, France, 86021, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 28, 2025

Study Start

April 3, 2025

Primary Completion

April 5, 2025

Study Completion

April 6, 2025

Last Updated

June 4, 2025

Record last verified: 2025-03

Locations