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Vascular Access DevicesNCT07870876

Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care

A study testing Training program on long peripheral catheter insertion in people with Vascular Access Devices and Vascular Access, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The purpose of this study is to evaluate the impact of a training intervention aimed at nursing personnel on the appropriateness of the indication of long peripheral venous catheters in candidate pediatric and neonatal patients, comparing the clinical practice of nursing personnel before and after the intervention. Read more about this study

Who is it for?
Any age
What is being tested?
Training program on long peripheral catheter insertion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Nursing professionals:
  • Nurses working in the Pediatric and Neonatology Service of the Hospital Universitario Fundación Jiménez Díaz (pediatric ward, Pediatric Intensive Care Unit or Neonatology Unit)
  • Voluntary participation in the training program on ultrasound-guided vascular assessment, long peripheral venous catheter insertion and implementation of the care protocol
  • Signed informed consent
  • Patients:
  • Patients from birth to 17 years of age admitted to the pediatric ward, the Pediatric Intensive Care Unit or the Neonatology Unit
  • Expected to require intravenous treatment through a peripheral line for more than 3 days
  • Informed consent signed by parents or legal guardians, and assent from patients older than 12 years

Who cannot join

  • Nursing professionals:
  • Nurses who do not wish to participate voluntarily in the study
  • Professionals from outside the Pediatric and Neonatology Service
  • Patients:
  • Candidates for central venous access, due to the characteristics of the drug (pH and osmolarity) or to their underlying condition
  • Candidates for a midline catheter
Show all 10Show fewer
  • Patients with a functioning central venous catheter already in place
  • Patients transferred from another hospital with a previously inserted venous catheter
  • Patients unable to complete follow-up due to transfer to another hospital
  • Patients whose peripheral venous line was inserted by a nurse not participating in the study

About this study

Official title: Impact of a Formative Intervention and the Implementation of a Protocol in the Use of Long Peripheral Venous Catheters in Pediatrics and Neonatology: A Prospective Comparative Study

The purpose of this study is to evaluate the impact of a training intervention aimed at nursing personnel on the appropriateness of the indication of long peripheral venous catheters in candidate pediatric and neonatal patients, comparing the clinical practice of nursing personnel before and after the intervention.

Study Design: Prospective, unicentric quality improvement study.

Read more

The study consists of three phases:

  1. -Pre-intervention phase: prospective collection of data from routine clinical practice, with a descriptive character, in relation to the use of catheters Venous short peripheral and long.
  2. -Educational intervention: structured training directed to nursing staff about indications, technique and care of the catheters Venous long peripherals, including specific training in the ultrasound assessment of the venous tree as a support tool for the selection of the most suitable vein for the cannulation of the catheter.
  3. -Post-intervention phase: protocol implementation of use of catheters Venous Long peripherals and prospective data collection of all peripheral venous accesses (short and long) in order to evaluate changes in clinical practice and results after the intervention. Likewise, the post-intervention phase will include a follow-up period with the objective of evaluating the sustainability of the effects of the intervention over time.

The collection of data over a prolonged period is contemplated, can be extended up to 24 months after the intervention, to analyze the maintenance of the adequacy in the indication of peripheral venous catheters, the incidence of complications and the stability of the clinical results. In a complementary way, the maintenance of the knowledge acquired by the nursing staff and the adherence to the protocol in routine clinical practice will be assessed.

Study Population and Total Number of Patients: The study population is structured in two levels: professional population (intervention) and clinical population (pre- and post-intervention).

  1. Professional population (intervention phase) The study population corresponding to the intervention phase will consist of the group of nursing professionals of the Pediatric and Neonatology Service of the Jiménez Díaz Foundation University Hospital , who participate in the training intervention on ultrasound vascular assessment, channeling of long peripheral venous catheters and implementation of the care protocol. The service has a care staff of 21 nursing professionals (approximately 3 to 5 per shift), distributed among the pediatric hospitalization floor, Pediatric Intensive Care Unit (PICU) and Neonatology Unit. Regarding their characteristics, the age of the professionals is approximately between 25 and 50 years, with an estimated average of around 35-40 years. Professional seniority varies between approximately 1 and 30 years of experience. The training intervention will be offered to all staff of the Pediatric Service, although participation will be voluntary, so no sample calculation is established at this stage. The following will be evaluated for this population:
  • Knowledge before and after training.
  • Satisfaction with training.
  • Satisfaction with the use of long peripheral venous catheters.
  • Adherence to the implemented protocol.
  1. Clinical population: Hospitalized pediatric patients will be included, from birth to 17 years of age, admitted to the pediatric hospitalization unit, the PICU and the Neonatology Unit, who are expected to require intravenous treatment by peripheral line for more than three days and whose parents or legal guardians give informed consent to participate and informed assent in the case of patients older than 12 years.

Schedule and Expected Date of Completion: The study is expected to begin in September 2026 , subject to obtaining approval from the Research Ethics Committee. The development period of the study will extend until October 2028 , including the preparation phase, the collection of pre-intervention data, the implementation of the training intervention and the subsequent follow-up of the participants and pediatric and neonatal patients. The study includes a short-, medium- and long-term follow-up, as well as the closing phase, data analysis and writing of the final report. These dates are estimates and could be adjusted according to the evolution of data collection and clinical follow-up.

Read the detailed description

Venous cannulation is a common and universal practice, being one of the most frequent invasive interventions in the hospital setting, not without morbidity at times. It consists of direct access to the vascular tree of the patient for therapeutic, diagnostic and monitoring purposes.

Its implementation requires that nursing personnel have updated knowledge based on scientific evidence to select the appropriate vascular catheter and choose the most suitable vein, as well as an adequate technique of insertion, use and maintenance of the catheter. All this with the purpose of providing safe, homogeneous, and quality care to the patient.

The challenge increases in pediatric patients due to their anatomophysiological characteristics, limited collaboration, and the higher frequency of complications related to vascular access, which can cause treatment interruptions and generate emotional stress for both the child and the family due to the need for vascular access. repeated channeling; to identify pediatric patients with difficult venous access, tools such as the DIVA (Difficult Intravenous Access) scale are used, adapted to Spanish as DIVA Score - SP.

The choice of the type of catheter depends on the type of medication, the duration of treatment, and the characteristics of the patient. This decision is crucial for success.

Currently, venous vascular access devices (VAD) are divided, according to the location of the catheter tip, into peripheral venous catheters and central venous catheters.

Three types of peripheral venous catheters are distinguished: short peripheral catheter, long peripheral catheter (minimidline) and midline catheter.

However, the present study will focus exclusively on short and long peripheral catheters, which are the devices subject to intervention and analysis.

Midline catheters were excluded because they are mainly indicated for intravenous therapies of prolonged duration, usually several weeks or even months, a care context that does not correspond to the usual clinical practice of our center. In our hospital, the intravenous treatments administered generally have a shorter duration, so the use of mini-midline catheters is more appropriate, as they are indicated for short-to-medium duration therapies, approximately one to two weeks.

In addition, midline catheters are channeled into deep veins, which can hinder the early detection of certain local complications, as they manifest later clinically compared to short and long peripheral catheters.

Short peripheral catheters have several limitations. Its duration is limited, approximately 2-3 days. Other factors that contribute to its limitations include the rigidity and low biocompatibility of the material and its potential complications.

These limitations lead to the removal of the catheter and, frequently, the placement of a new one, causing interruptions of therapy, increasing hospital costs, vascular exhaustion, as well as pain, anxiety of the patient/family, and distress in the nursing staff.

The failures of this device are due to three factors: patient, device or insertion technique, with some being preventable by appropriate prevention and management measures, including the correct choice of the type of catheter.

In recent years, long peripheral catheters have emerged as an alternative to short peripheral catheters, offering a longer duration and lower risk of complications. These devices, usually made of polyurethane and with lengths that vary between 6 and 15 cm, are inserted in superficial veins of the arm or forearm by direct technique or, in deep venous vessels, under ultrasound guidance, with the tip of the device located in the veins. basilic, brachial or cephalic, which never exceeds the axilla.

The available evidence shows that these catheters, compared to short ones, provide a more stable and longer-lasting vascular access, reducing the frequency of complications and the need for repeated venipunctures. This contributes to improving safety, efficiency of care, the experience of the patient and their families, and optimizing hospital costs.

It has a number of advantages over short peripheral catheters, including a lower number of complications, due to the following:

  • Manufacturing material : made with materials of greater biocompatibility, which reduces irritation of the venous wall and the incidence of local complications.
  • Longest length:

Location of the tip: the tip of the catheter is placed in a vein of larger caliber, with greater blood flow and better hemodilution, decreasing chemical irritation and the risk of chemical phlebitis, infiltration and patient discomfort.

Mechanical stability: greater length of the catheter within the vessel provides more secure fixation, reducing the risk of displacement or accidental exit and helping to minimize PFC (phlebitis complications).

-Insertion technique : the use of the Seldinger technique allows a more controlled cannulation, reducing venous trauma and local complications.

On the other hand, the use of long peripheral venous catheters is often associated with the use of ultrasound as a support tool compared to short peripheral catheters, which provides several advantages:

  • Cannulation: Ultrasound-guided cannulation of long peripheral tracts increases the success of insertion, decreasing the number of venipunctures.
  • Previous assessment of the vein: allows the selection of the most suitable vein and the appropriate size of the catheter for its cannulation. This technique has been used in several studies as part of the methodology of insertion of long peripheral catheters.

However, despite the fact that recent studies and research suggest the use of long peripheral venous catheters when a prolonged treatment is required in the pediatric population, in routine clinical practice its use continues to be limited, mainly due to the lack of updated protocols and the limited specific training of personnel. The use of short peripheral venous catheters predominates even in patients potentially candidates for long catheters.

Several studies have described relevant rates of complications and failure associated with the use of short peripheral venous catheters in the pediatric population, as well as differences in clinical results when compared with long peripheral catheters.

This discrepancy between the available evidence and clinical practice justifies the need to develop strategies aimed at improving the adequacy in the choice of venous access device. In this context, the implementation of an intervention aimed at nursing personnel is proposed with the aim of increasing the appropriate use of long peripheral catheters in pediatric and neonatal patients.

The results of this work could contribute to improving the quality of care, reducing the number of venipunctures, minimizing the pain and anxiety of the patient and their family, reducing the emotional and care burden of the nursing staff and optimizing the use of resources. available.

Finally, this study presents a clear practical applicability, since it will allow the development and implementation of a protocol validated for cannulation of long peripheral venous catheters in pediatrics, based on the available scientific evidence, as well as the design and development of a specific training plan for pediatric nursing personnel. These actions aim to improve adherence to evidence-based practices, contributing to safer, more efficient, and higher-quality pediatric care.

Hypothesis: The implementation of a training intervention aimed at nursing personnel will increase the adequacy in the indication of long peripheral venous catheters in candidate pediatric and neonatal patients, compared to usual clinical practice prior to the intervention.

Primary objective

-To evaluate the impact of a training intervention aimed at nursing personnel on the appropriateness of the indication of long peripheral venous catheters in candidate pediatric and neonatal patients, comparing the clinical practice of nursing personnel before and after the intervention.

Secondary Objectives

  • Complications and clinical results:
  • To evaluate the incidence of complications associated with peripheral venous access in pediatric and neonatal patients before and after the formative intervention.
  • To analyze the incidence of complications associated with peripheral venous access according to age groups.
  • To compare the longevity of peripheral venous catheters (short and long) before and after the formative intervention in pediatric and neonatal patients.
  • To evaluate the need for new peripheral venous cannulations before and after the formative intervention in pediatric and neonatal patients.
  • Clinical practice and appropriateness:
  • To evaluate the adequacy in the choice of device (short vs. long) according to the expected duration of intravenous treatment before and after the formative intervention.
  • To analyze the changes in the proportion of use of long and short peripheral venous catheters before and after the educational intervention.
  • To evaluate the differences in direct health costs of materials associated with the procedure of cannulation of short peripheral venous catheters compared to long peripheral venous catheters in pediatric and neonatal patients.
  • Educational intervention and professionals:
  • To create a standardized protocol for the placement of long peripheral venous catheters in the pediatric service.
  • To develop, implement and evaluate a training plan in the placement of long peripheral catheters for nurses of the pediatric service in order to improve adherence to the placement of this type of catheter.
  • To evaluate the change in the level of knowledge of nurses in the pediatric service about the channeling, indications, complications and care of long peripheral venous catheters before and after the training intervention.
  • To evaluate the degree of satisfaction of nursing professionals with the training plan implemented.
  • To evaluate the degree of satisfaction of nursing professionals regarding the use of long peripheral venous catheters in clinical practice.
Being tested
Training program on long peripheral catheter insertion
Keywords
Nursing education, Catheter-related complications, Long peripheral intravenous catheter, Vascular access, Pediatric, Neonatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training program on long peripheral catheter insertionBehavioural

    Structured educational program for pediatric nurses on the insertion and maintenance of long peripheral catheters. The program combines theoretical content and hands-on practical training. Content includes indications and device selection, insertion technique, aseptic technique, catheter securement and maintenance, and early recognition and prevention of complications such as phlebitis, occlusion, infiltration, and accidental dislodgement.

Study groups in NCT07870876
Study groupRoleWhat they receive
Training Program on Long Peripheral Venous CathetersExperimentalSingle group, pre-post design. Pediatric nurses receive a training program on long peripheral catheters. Outcomes are measured in the participating nurses and in the pediatric and neonatal patients they care for, before and after the training.
Receives: Behavioral: Training program on long peripheral catheter insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Long Peripheral Venous Catheter Insertions With an Appropriate Indication

    Percentage of long peripheral venous catheter insertions performed by participating nurses in pediatric and neonatal patients whose indication meets the unit's protocol criteria for long peripheral catheters. The appropriateness of the indication will be recorded at each insertion using an ad hoc data collection form. Calculated as (number of insertions with an appropriate indication / total number of long peripheral venous catheter insertions) x 100. The baseline pre-intervention period will be compared with each post-intervention data collection window.

    Measured: Baseline (3-month pre-intervention period) and 0-3, 6-9 and 12-15 months after completion of the training program

  2. Change From Baseline in Nurses' Knowledge Score on Long Peripheral Venous Catheters

    Knowledge of participating nurses about long peripheral venous catheters (indications and device selection, insertion technique, aseptic technique, securement and maintenance, and prevention and early recognition of complications) will be assessed with an ad hoc questionnaire of multiple-choice items. The score is expressed as the percentage of correct answers (range 0-100%), where higher scores indicate greater knowledge. Results will be reported as the change from the pre-training score at each post-training time point.

    Measured: Baseline, immediately after completion of the training program, and at 3, 6 and 12 months after completion of the training program

Secondary outcomes (1)
  1. Percentage of Peripheral Venous Catheters With at Least One Complication

    Percentage of peripheral venous catheters in pediatric and neonatal patients cared for by participating nurses that present at least one complication between insertion and removal. Complications include phlebitis, infiltration/extravasation, occlusion and accidental dislodgement, assessed by nursing staff and recorded on an ad hoc data collection form. Calculated as (number of catheters with at least one complication / total number of catheters) x 100. The baseline pre-intervention period will be compared with each post-intervention data collection window. Results will also be reported by age group.

    Measured: Baseline (3-month pre-intervention period) and 0-3, 6-9 and 12-15 months after completion of the training program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Single-group pre-post study. Pediatric nurses (approximately 20) receive a structured training program on long peripheral catheters. Outcomes are assessed at two levels: (1) participating nurses, through a knowledge test administered before the training, immediately after, and at 3, 6 and 12 months; and (2) pediatric and neonatal patients cared for by participating nurses, through data on the indication and complications of peripheral venous catheters collected during a 3-month baseline period before the training and during 3-month windows at 0-3, 6-9 and 12-15 months after the training. The sample size calculation requires a minimum of 33 patients per data collection window. Enrollment includes both nurses and patients.
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07870876
Sponsor's protocol ID
PIC-078-26_FJD
Status last verified
Oct 2026
First submitted
28 Sep 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Training program on long peripheral catheter insertion in people with Vascular Access Devices and Vascular Access, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.

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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of Long Peripheral Venous Catheter Insertions With an Appropriate Indication (time frame: Baseline (3-month pre-intervention period) and 0-3, 6-9 and 12-15 months after completion of the training program). The study lists 2 primary outcomes in all. 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 16 Oct 2026.

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