Clinical trial NCT06851585: Failure of First-attempt Insertion and Analysis of Practices Related to Peripheral Intravenous Catheters in the Emergency Department:
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheterization
Catheterization, Peripheral
Catheters
Vascular Access Devices
Emergency Departments
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 4312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients requiring a CVP in an emergency department can participate in the study

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).


Eligibility criteria: 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

Primary outcomes:
measure: Estimate the prevalence of first-attempt PIVC insertion failure
timeFrame: 24 hours
Secondary outcomes:
measure: Analyse practices related to the insertion and maintenance of PIVCs
timeFrame: 24 hours
measure: Estimate the percentage of patients presenting with criteria for Difficult Vascular Access
timeFrame: 24 hours
measure: Assess the association between first-attempt insertion failure and the presence of Difficult Vascular Access criteria
timeFrame: 24 hours
measure: Identify the demographic criteria impacting vascular access and predicting failure of insertion at the first attempt
timeFrame: 24 hours
measure: Estimate the prevalence of unnecessary catheters placed in the emergency room
timeFrame: 24 hours
measure: Identify the demographic criteria of centers impacting the incidence of unnecessary catheters placed in emergency departments
timeFrame: 24 hours
measure: Determine the frequency of use of different vein approach techniques
timeFrame: 24 hours
measure: Determine the frequency of use of alternative vascular access in the event of failure of installation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References: