Vascular Access DevicesINSERT/2022NCT06290284
Comparison Between Mini-midline and the Peripheral Intravenous Catheter
A study testing Long Peripheral Catheter and Peripheral Intra-Venous Catheter in people with Vascular Access Devices and Venous Puncture, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Devices, Venous Puncture
- What is being tested?
- Long Peripheral Catheter and Peripheral Intra-Venous Catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2023to 28 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- High probability of hospital admission
- Sufficient venous patrimony according to EA-DIVA scale score
Who cannot join
- Patients already having a venous access in place
- Patients requiring life-saving treatments
- Patients seeking ambulatory care
- Patients unable to express informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Comparison Between the Long (Mini-midline) and the Short Catheter (Peripheral Intravenous Catheter) in the Reduction of Venipunctures During Hospital Stay: a Randomized Controlled Trial
The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.
The main questions it aims to answer are:
- Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;
- Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.
Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms.
Read the detailed description
A standard peripheral intravenous catheter (PIVC) or a mini-midline (LPC) will be placed according to routine clinical indications (i.e., for blood withdrawal and IV drug therapy) in patients seeking care at the Emergency Department. On admission at the Emergency Department triage desk, patients will be assigned a triage code according to clinical assessment by the triage nurse and will be evaluated as to the probability of being eventually admitted to hospital. Following enrollment, patients will be randomly assigned to receive LPC or PIVC. The follow-up period begins after catheter placement and continues through transfer to a hospital ward. During this period of catheter management, the insertion site and dressing will be monitored.
- Conditions
- Vascular Access Devices, Venous Puncture
- Being tested
- Long Peripheral Catheter, Peripheral Intra-Venous Catheter
- Keywords
- Vascular access, Emergency Department, Long Peripheral Catheter, Peripheral Intra-Venous Catheter
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Peripheral CatheterProcedure or surgery
PowerGlide Pro™ Midline Catheter
Peripheral Intra-Venous CatheterProcedure or surgery
Venflon™ Pro Safety Needle Protected IntraVenous Cannula
| Study group | Role | What they receive |
|---|---|---|
| Long Peripheral Catheter | Experimental | The procedure to place a LPC includes these steps: before inserting the catheter, the nurse will perform routine preliminary (non sterile) inspection of the arm to identify an insertion site. After selecting the insertion site, the nurse will release the tourniquet, with non-sterile gloves, and disinfect the skin around the insertion site. While allowing the antiseptic to act, the nurse will apply the tourniquet, and pull lightly with the thumb of the non-dominant hand to keep the vein from moving. After the needle has been inserted in the vein lumen, the guide wire is advanced and the catheter is inserted using the catheter wings. As the catheter is being inserted, the sheath (housing) is removed and then the wings. Before attaching the catheter to an extension without a needle or to a 3-way stopcock, it should be connected to a statlock to ensure it is safely fixated. A transparent, semi-permeable dressing will allow for daily visual inspection of the insertion site. Receives: Procedure: Long Peripheral Catheter |
| Peripheral Intra-Venous Catheter | Active comparator | The procedure to place a PIVC includes these steps: before inserting the catheter, the nurse will perform routine preliminary (non sterile) inspection of the arm to identify an insertion site. After selecting the insertion site, the nurse will release the tourniquet, with non-sterile gloves, and disinfect the skin around the insertion site. While allowing the antiseptic to act, the nurse will apply the tourniquet, and pull lightly with the thumb of the non-dominant hand to keep the vein from moving. The needle will be inserted at a 10-30 degree angle about 1-2 cm distal from the catheter insertion site. Holding the needle firmly, the nurse will advance the cannula for its entire length into the lumen, remove the needle, and connect the cannula via an extension to a 3-way stopcock. A transparent, semi-permeable dressing will allow for daily visual inspection of the insertion site. Receives: Procedure: Peripheral Intra-Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion
Difference between the two study arms in the proportion of patients who required a venipuncture after insertion of the PIVC or the LPC.
Measured: The catheter will be evaluated within 24 hours after the placement
Secondary outcomes (1)
Adverse events associated with use of LPC and PIVC
Number of adverse events (e.g., thrombophlebitis, extravasation, inflammation of the insertion site) monitored also using the Visual Infusion Phlebitis Score
Measured: Adverse will be evaluated every 24 hours till the catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start25 Sep 2023
- Primary completion17 Nov 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular Access DevicesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Galazzi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Alessandro Galazzi, PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290284
- Sponsor's protocol ID
- 6322
- Acronym
- INSERT/2022
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Civetta G, Cortesi S, Mancardi M, De Pirro A, Vischio M, Mazzocchi M, Scudeller L, Bottazzi A, Iotti GA, Palo A. EA-DIVA score (Enhanced Adult DIVA score): A new scale to predict difficult preoperative venous cannulation in adult surgical patients. J Vasc Access. 2019 May;20(3):281-289. doi: 10.1177/1129729818804994. Epub 2018 Oct 16.
PubMed 30324841Binda F, Galazzi A, Marelli F, Salinaro G, de Vecchi M, Spagna S, Marcotullio A, Calegari J, Laquintana D, Gambazza S. Long versus conventional peripheral intravenous catheters to reduce venipunctures during hospital stay: A randomized controlled trial. J Vasc Access. 2026 May;27(3):1122-1132. doi: 10.1177/11297298251385595. Epub 2025 Nov 3.
PubMed 41185485
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Long (Mini-midline) and the Short Catheter (Peripheral Intravenous Catheter) in the Reduction of Venipunctures During Hospital Stay: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06290284
- Acronym / sponsor ID
- INSERT/2022 / 6322
- Conditions
- Vascular Access Devices, Venous Puncture
- Keywords
- Vascular access, Emergency Department, Long Peripheral Catheter, Peripheral Intra-Venous Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 4 Mar 2024 (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.
The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.
The main questions it aims to answer are:
- Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;
- Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.
Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms.
Detailed description
A standard peripheral intravenous catheter (PIVC) or a mini-midline (LPC) will be placed according to routine clinical indications (i.e., for blood withdrawal and IV drug therapy) in patients seeking care at the Emergency Department. On admission at the Emergency Department triage desk, patients will be assigned a triage code according to clinical assessment by the triage nurse and will be evaluated as to the probability of being eventually admitted to hospital. Following enrollment, patients will be randomly assigned to receive LPC or PIVC. The follow-up period begins after catheter placement and continues through transfer to a hospital ward. During this period of catheter management, the insertion site and dressing will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Peripheral Catheter | Experimental | Procedure: Long Peripheral CatheterThe procedure to place a LPC includes these steps: before inserting the catheter, the nurse will perform routine preliminary (non sterile) inspection of the arm to identify an insertion site. After selecting the insertion site, the nurse will release the tourniquet, with non-sterile gloves, and disinfect the skin around the insertion site. While allowing the antiseptic to act, the nurse will apply the tourniquet, and pull lightly with the thumb of the non-dominant hand to keep the vein from moving. After the needle has been inserted in the vein lumen, the guide wire is advanced and the catheter is inserted using the catheter wings. As the catheter is being inserted, the sheath (housing) is removed and then the wings. Before attaching the catheter to an extension without a needle or to a 3-way stopcock, it should be connected to a statlock to ensure it is safely fixated. A transparent, semi-permeable dressing will allow for daily visual inspection of the insertion site. |
| Peripheral Intra-Venous Catheter | Active comparator | Procedure: Peripheral Intra-Venous CatheterThe procedure to place a PIVC includes these steps: before inserting the catheter, the nurse will perform routine preliminary (non sterile) inspection of the arm to identify an insertion site. After selecting the insertion site, the nurse will release the tourniquet, with non-sterile gloves, and disinfect the skin around the insertion site. While allowing the antiseptic to act, the nurse will apply the tourniquet, and pull lightly with the thumb of the non-dominant hand to keep the vein from moving. The needle will be inserted at a 10-30 degree angle about 1-2 cm distal from the catheter insertion site. Holding the needle firmly, the nurse will advance the cannula for its entire length into the lumen, remove the needle, and connect the cannula via an extension to a 3-way stopcock. A transparent, semi-permeable dressing will allow for daily visual inspection of the insertion site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- High probability of hospital admission
- Sufficient venous patrimony according to EA-DIVA scale score
Key exclusion criteria (4 listed)
- Patients already having a venous access in place
- Patients requiring life-saving treatments
- Patients seeking ambulatory care
- Patients unable to express informed consent
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 |
|---|---|---|
| Long Peripheral CatheterPowerGlide Pro™ Midline Catheter | Procedure or surgery | Long Peripheral Catheter |
| Peripheral Intra-Venous CatheterVenflon™ Pro Safety Needle Protected IntraVenous Cannula | Procedure or surgery | Peripheral Intra-Venous Catheter |
Primary outcome
Difference in proportion
Time frame: The catheter will be evaluated within 24 hours after the placement
Difference between the two study arms in the proportion of patients who required a venipuncture after insertion of the PIVC or the LPC.
1 secondary outcome
Adverse events associated with use of LPC and PIVC
Time frame: Adverse will be evaluated every 24 hours till the catheter removal
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 Mar 2024.
- Background: PubMed 30324841Civetta G, Cortesi S, Mancardi M, De Pirro A, Vischio M, Mazzocchi M, Scudeller L, Bottazzi A, Iotti GA, Palo A. EA-DIVA score (Enhanced Adult DIVA score): A new scale to predict difficult preoperative venous cannulation in adult surgical patients. J Vasc Access. 2019 May;20(3):281-289. doi: 10.1177/1129729818804994. Epub 2018 Oct 16.
- Derived from this study: PubMed 41185485Binda F, Galazzi A, Marelli F, Salinaro G, de Vecchi M, Spagna S, Marcotullio A, Calegari J, Laquintana D, Gambazza S. Long versus conventional peripheral intravenous catheters to reduce venipunctures during hospital stay: A randomized controlled trial. J Vasc Access. 2026 May;27(3):1122-1132. doi: 10.1177/11297298251385595. Epub 2025 Nov 3.
- Individual participant dataSharing planned: No
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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.
Alessandro Galazzi, PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long Peripheral Catheter and Peripheral Intra-Venous Catheter in people with Vascular Access Devices and Venous Puncture, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 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 Mar 2024. 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 Italy. 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?
Difference in proportion (time frame: The catheter will be evaluated within 24 hours after the placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290284, which also lists 2 linked publications.
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 Mar 2024.