CatheterizationCATHIRUNCT06851585
Failure of First-attempt Insertion and Analysis of Practices Related to Peripheral Intravenous Catheters in the Emergency Department:
An observational study of Catheterization and Catheterization, Peripheral, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Catheterization, Peripheral, Catheters
- What is being tested?
- CathIRU Cohort
- Type of treatment
- Medical device
- How many people
- 4,312 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2025to 6 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients requiring a CVP in an emergency department can participate in the study
Who may be able to join
- Adult over 18 years old
- Requiring peripheral vascular access
- Having provided oral consent for data collection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
- Conditions
- Catheterization, Catheterization, Peripheral, Catheters, Vascular Access Devices, Emergency Departments
- Being tested
- CathIRU Cohort
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CathIRU CohortDevice
All adult patients requiring a CVP in an emergency department can participate in the study
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients with attempted vascular access insertion | Not described Receives: Device: CathIRU Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (8)
Analyse practices related to the insertion and maintenance of PIVCs
Measured: 24 hours
Estimate the percentage of patients presenting with criteria for Difficult Vascular Access
Measured: 24 hours
Assess the association between first-attempt insertion failure and the presence of Difficult Vascular Access criteria
Measured: 24 hours
Identify the demographic criteria impacting vascular access and predicting failure of insertion at the first attempt
Measured: 24 hours
Estimate the prevalence of unnecessary catheters placed in the emergency room
Measured: 24 hours
Identify the demographic criteria of centers impacting the incidence of unnecessary catheters placed in emergency departments
Measured: 24 hours
Determine the frequency of use of different vein approach techniques
Measured: 24 hours
Determine the frequency of use of alternative vascular access in the event of failure of installation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start3 Apr 2025
- Primary completion5 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,312 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851585
- Sponsor's protocol ID
- CATHIRU
- Acronym
- CATHIRU
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06851585
- Acronym / sponsor ID
- CATHIRU / CATHIRU
- Conditions
- Catheterization, Catheterization, Peripheral, Catheters, Vascular Access Devices, Emergency Departments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,312 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients with attempted vascular access insertion | – | Device: CathIRU Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients requiring a CVP in an emergency department can participate in the study
Key inclusion criteria (3 listed)
- Adult over 18 years old
- Requiring peripheral vascular access
- Having provided oral consent for data collection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CathIRU CohortAll adult patients requiring a CVP in an emergency department can participate in the study | Device | Cohort of patients with attempted vascular access insertion |
Primary outcome
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.
8 secondary outcomes
Analyse practices related to the insertion and maintenance of PIVCs
Time frame: 24 hours
Estimate the percentage of patients presenting with criteria for Difficult Vascular Access
Time frame: 24 hours
Assess the association between first-attempt insertion failure and the presence of Difficult Vascular Access criteria
Time frame: 24 hours
Identify the demographic criteria impacting vascular access and predicting failure of insertion at the first attempt
Time frame: 24 hours
Estimate the prevalence of unnecessary catheters placed in the emergency room
Time frame: 24 hours
Identify the demographic criteria of centers impacting the incidence of unnecessary catheters placed in emergency departments
Time frame: 24 hours
Determine the frequency of use of different vein approach techniques
Time frame: 24 hours
Determine the frequency of use of alternative vascular access in the event of failure of installation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheterization and Catheterization, Peripheral, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the prevalence of first-attempt PIVC insertion failure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.