Vascular Access DevicesNCT05884294
Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients
A study testing PowerGlide Pro Midline catheter. in people with Vascular Access Devices, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This research seeks to compare two types of vascular access (catheters that are inserted into the vein) for patient treatment during hospitalization. This research will evaluate how long each catheter lasts before presenting problems that may lead to its removal from the vein (the most common are swelling on the site… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Devices
- What is being tested?
- PowerGlide Pro Midline catheter.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2024to 1 Mar 2025
- 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
- patients hospitalized in a clinical ward unit;
- indicated for continuous or intermittent intravenous therapy more than five days;
- identified with difficult intravenous access.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 903
About this study
Official title: Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients: Randomized Clinical Trial With Economic Analysis From the Perspective of the Public Health System.
This research seeks to compare two types of vascular access (catheters that are inserted into the vein) for patient treatment during hospitalization. This research will evaluate how long each catheter lasts before presenting problems that may lead to its removal from the vein (the most common are swelling on the site of the catheter, clogging of the catheter, infections, or other less common problems. Each patient will be randomly selected to receive either catheter. In this study, we will also estimate how much each patient will spend if any of the problems mentioned occur.
Read the detailed description
This randomized, parallel, open, controlled, single-center clinical trial is blind to outcome analysis. The use of midline catheter will be compared, regarding duration of use without complications, to the use of long peripheral intravenous catheter during continuous our intermittent intravenous therapy in adult clinical patients who have been hospitalized for up to 30 days. The intervention group will consist of hospitalized adult clinical patients who were identified with difficult intravenous access (DIVA) and who received medical indication of continuous or intermittent intravenous therapy for more than five and a maximum of 30 days of treatment. These patients will receive PowerGlide ProTM Midline catheter. The control group will consist of patients with the same profile described as the intervention group and will receive the insertion of a long peripheral venous catheter Introcan Safety Deep Access. At the end of the study, an economic analysis will be carried out from the perspective of the public health system if the intervention group shows favorable results.
- Conditions
- Vascular Access Devices
- Being tested
- PowerGlide Pro Midline catheter.
- Keywords
- vascular access device, midline catheter, long Peripheral Intravenous Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerGlide Pro Midline catheter.Device
The Intervention Group will be represented by hospitalized adult clinical patients who have been identified with difficult intravenous access. These patients will receive an ultrasound-guided insertion of the PowerGlide ProTM Midline 20G (10 cm).
| Study group | Role | What they receive |
|---|---|---|
| PowerGlide Pro Midline catheter. | Experimental | The Intervention Group will be represented by hospitalized adult clinical patients who have been identified with difficult intravenous access. These patients will receive an ultrasound-guided insertion of the PowerGlide ProTM Midline 20G (10 cm). Receives: Device: PowerGlide Pro Midline catheter. |
| Introcan Safety Deep Access long peripheral venous catheter. | No intervention | The control group will be subjected to the same selection criteria as the patients in the intervention group; however, they will receive an ultrasound-guided insertion of a long peripheral venous catheter Introcan Safety Deep Access 20G (6.4 cm). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenght of time of vascular access without isolated or combined complications.
Time in days.
Measured: up to 30 days, end of therapy or withdrawal due to any complication
Secondary outcomes (1)
First-attempt puncture success
success in the first venipuncture, number venipuncture.
Measured: up to 30 days or end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start2 Jan 2024
- Primary completion27 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access DevicesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, parallel, open, controlled, and single-center clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eneida R Rabelo da Silva, ScD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884294
- Sponsor's protocol ID
- 2022-0363
- Status last verified
- Jun 2025
- First submitted
- 27 Jan 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teixeira TO, Hansel LA, Ceratti RDN, Brum ID, Fernandes AGDS, Saline CG, Junges M, Rabelo-Silva ER. Midline catheter (10 cm) versus long peripheral intravenous catheter (6.4 cm): Randomized clinical trial protocol with economic analysis. PLoS One. 2025 Apr 24;20(4):e0319587. doi: 10.1371/journal.pone.0319587. eCollection 2025.
PubMed 40273075
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients: Randomized Clinical Trial With Economic Analysis From the Perspective of the Public Health System.
- ClinicalTrials.gov ID
- NCT05884294
- Acronym / sponsor ID
- 2022-0363
- Conditions
- Vascular Access Devices
- Keywords
- vascular access device, midline catheter, long Peripheral Intravenous Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 1 Jun 2023 (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.
This research seeks to compare two types of vascular access (catheters that are inserted into the vein) for patient treatment during hospitalization. This research will evaluate how long each catheter lasts before presenting problems that may lead to its removal from the vein (the most common are swelling on the site of the catheter, clogging of the catheter, infections, or other less common problems. Each patient will be randomly selected to receive either catheter. In this study, we will also estimate how much each patient will spend if any of the problems mentioned occur.
Detailed description
This randomized, parallel, open, controlled, single-center clinical trial is blind to outcome analysis. The use of midline catheter will be compared, regarding duration of use without complications, to the use of long peripheral intravenous catheter during continuous our intermittent intravenous therapy in adult clinical patients who have been hospitalized for up to 30 days. The intervention group will consist of hospitalized adult clinical patients who were identified with difficult intravenous access (DIVA) and who received medical indication of continuous or intermittent intravenous therapy for more than five and a maximum of 30 days of treatment. These patients will receive PowerGlide ProTM Midline catheter. The control group will consist of patients with the same profile described as the intervention group and will receive the insertion of a long peripheral venous catheter Introcan Safety Deep Access. At the end of the study, an economic analysis will be carried out from the perspective of the public health system if the intervention group shows favorable results.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, parallel, open, controlled, and single-center clinical trial.
| Arm | Type | Receives |
|---|---|---|
| PowerGlide Pro Midline catheter. | Experimental | Device: PowerGlide Pro Midline catheter.The Intervention Group will be represented by hospitalized adult clinical patients who have been identified with difficult intravenous access. These patients will receive an ultrasound-guided insertion of the PowerGlide ProTM Midline 20G (10 cm). |
| Introcan Safety Deep Access long peripheral venous catheter. | No intervention | –The control group will be subjected to the same selection criteria as the patients in the intervention group; however, they will receive an ultrasound-guided insertion of a long peripheral venous catheter Introcan Safety Deep Access 20G (6.4 cm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PowerGlide Pro Midline catheter.The Intervention Group will be represented by hospitalized adult clinical patients who have been identified with difficult intravenous access. These patients will receive an ultrasound-guided insertion of the PowerGlide ProTM Midline 20G (10 cm). | Device | PowerGlide Pro Midline catheter. |
Primary outcome
Lenght of time of vascular access without isolated or combined complications.
Time frame: up to 30 days, end of therapy or withdrawal due to any complication
Time in days.
1 secondary outcome
First-attempt puncture success
Time frame: up to 30 days or end of therapy
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 18 Jun 2025.
- Derived from this study: PubMed 40273075Teixeira TO, Hansel LA, Ceratti RDN, Brum ID, Fernandes AGDS, Saline CG, Junges M, Rabelo-Silva ER. Midline catheter (10 cm) versus long peripheral intravenous catheter (6.4 cm): Randomized clinical trial protocol with economic analysis. PLoS One. 2025 Apr 24;20(4):e0319587. doi: 10.1371/journal.pone.0319587. eCollection 2025.
- 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.
Eneida R Rabelo da Silva, ScD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PowerGlide Pro Midline catheter. in people with Vascular Access Devices, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 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 Brazil. 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?
Lenght of time of vascular access without isolated or combined complications. (time frame: up to 30 days, end of therapy or withdrawal due to any complication). 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 NCT05884294, which also lists 1 linked publication.
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 18 Jun 2025.