PediatricsNCT07182994
Immobilization During Peripheral Venous Catheter Placement
A study testing Elbow joint immobilization and Arm restraint without elbow immobilization in people with Pediatrics and Immobilization, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Aim: To determine the most effective type of upper limb immobilization in the cannulation of a peripheral venous line in the pediatric emergency department. Methods: Randomized clinical trial with 322 patients conducted in a tertiary pediatric emergency. Read more about this study
- Who is it for?
- Ages 1 day to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatrics, Immobilization
- What is being tested?
- Elbow joint immobilization and Arm restraint without elbow immobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 28 Mar 2023
- Phase
- Interventional
- 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 1 day to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients at emergency department that need a peripheral venous line
Who cannot join
- Critically ill patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immobilization During Peripheral Venous Catheter Placement in Paediatric Emergency Care: a Randomized Clinical Trial
Aim: To determine the most effective type of upper limb immobilization in the cannulation of a peripheral venous line in the pediatric emergency department.
Methods: Randomized clinical trial with 322 patients conducted in a tertiary pediatric emergency. The impact of two types of restraints (immobilization of the elbow joint versus arm restraint, without immobilization of the elbow joint) on the success of the technique was analyzed. Multivariate analysis was used to analyze the impact of other variables (weight, age, movements, pain) on the success of the technique.
Read the detailed description
A study will be conducted in a Spanish tertiary hospital to assess the holding technique for peripheral venous catheterization in pediatric patients presenting to the pediatric emergency department. The nursing staff will be responsible for implementing the study protocol, data collection, and subsequent analysis.
- Conditions
- Pediatrics, Immobilization
- Being tested
- Elbow joint immobilization, Arm restraint without elbow immobilization
- Keywords
- pediatrics, emergency medical services, immobilization, catheter, nurses, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow joint immobilizationProcedure or surgery
Immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients on the success of the technique
Arm restraint without elbow immobilizationProcedure or surgery
Use of arm restraint without immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| elbow joint immobilization | Experimental | Pediatric patients undergo cannulation of a peripheral venous line with immobilization of the elbow joint Receives: Procedure: Elbow joint immobilization |
| arm restraint without immobilization of the elbow joint | Active comparator | Pediatric patients undergo cannulation of a peripheral venous line with arm restraint, but the elbow joint is not immobilized. Receives: Procedure: Arm restraint without elbow immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of peripheral venous line cannulation on the first attempt
Percentage of successful cannulations on the first attempt, as assessed by the registered nurse.
Measured: From enrollment to the end of the procedure (15 minutes)
Secondary outcomes (3)
Number of attempts required
Number of cannulation attempts until successful catheterization.
Measured: From enrollment to the end of the procedure (15 minutes)
Time to successful catheterization
Time in minutes from first attempt to successful catheter placement
Measured: From start of procedure until catheter placement (≤15 minutes)
Nurse's assessment of patient's pain
Pain assessed by the nurse using validated, age-appropriate pediatric pain scales:
- CRIES scale: Minimum score = 0, Maximum score = 10.
- FLACC scale: Minimum score = 0, Maximum score = 10.
- Groningen scale: Minimum score = 0, Maximum score = 5. For all scales, higher scores indicate worse pain outcomes.
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jun 2022
- Primary completion1 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Martínez Serrano, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182994
- Sponsor's protocol ID
- Immobilization catheter
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a small sample of pediatric patients in a single hospital. Sharing the data could compromise confidentiality despite de-identification, and the main outcomes will be disseminated through peer-reviewed publications and conference presentations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immobilization During Peripheral Venous Catheter Placement in Paediatric Emergency Care: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07182994
- Acronym / sponsor ID
- Immobilization catheter
- Conditions
- Pediatrics, Immobilization
- Keywords
- pediatrics, emergency medical services, immobilization, catheter, nurses, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 19 Sep 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.
Aim: To determine the most effective type of upper limb immobilization in the cannulation of a peripheral venous line in the pediatric emergency department.
Methods: Randomized clinical trial with 322 patients conducted in a tertiary pediatric emergency. The impact of two types of restraints (immobilization of the elbow joint versus arm restraint, without immobilization of the elbow joint) on the success of the technique was analyzed. Multivariate analysis was used to analyze the impact of other variables (weight, age, movements, pain) on the success of the technique.
Detailed description
A study will be conducted in a Spanish tertiary hospital to assess the holding technique for peripheral venous catheterization in pediatric patients presenting to the pediatric emergency department. The nursing staff will be responsible for implementing the study protocol, data collection, and subsequent analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elbow joint immobilization | Experimental | Procedure: Elbow joint immobilizationPediatric patients undergo cannulation of a peripheral venous line with immobilization of the elbow joint |
| arm restraint without immobilization of the elbow joint | Active comparator | Procedure: Arm restraint without elbow immobilizationPediatric patients undergo cannulation of a peripheral venous line with arm restraint, but the elbow joint is not immobilized. |
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients at emergency department that need a peripheral venous line
Key exclusion criteria (1 listed)
- Critically ill patient
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 |
|---|---|---|
| Elbow joint immobilizationImmobilization of the elbow joint during peripheral venous line cannulation in pediatric patients on the success of the technique | Procedure or surgery | elbow joint immobilization |
| Arm restraint without elbow immobilizationUse of arm restraint without immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients. | Procedure or surgery | arm restraint without immobilization of the elbow joint |
Primary outcome
success of peripheral venous line cannulation on the first attempt
Time frame: From enrollment to the end of the procedure (15 minutes)
Percentage of successful cannulations on the first attempt, as assessed by the registered nurse.
3 secondary outcomes
Number of attempts required
Time frame: From enrollment to the end of the procedure (15 minutes)
Time to successful catheterization
Time frame: From start of procedure until catheter placement (≤15 minutes)
Nurse's assessment of patient's pain
Time frame: Immediately after procedure
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 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a small sample of pediatric patients in a single hospital. Sharing the data could compromise confidentiality despite de-identification, and the main outcomes will be disseminated through peer-reviewed publications and conference presentations.
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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?
A study testing Elbow joint immobilization and Arm restraint without elbow immobilization in people with Pediatrics and Immobilization, run by Hospital Universitario La Paz at 1 site in Spain.
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 1 inclusion and 1 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 17 Sep 2026. 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 Spain. 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?
success of peripheral venous line cannulation on the first attempt (time frame: From enrollment to the end of the procedure (15 minutes)). 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 17 Sep 2026.