Catheter ComplicationsNCT06106659
Comparison of Clinical Outcomes of Mini Midline Catheters With Different Placement Sites: a Randomized Controlled Trial
A study testing Mini Midline in people with Catheter Complications, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Peripheral venous catheters are the most commonly used vascular access devices in healthcare today, including indwelling needles, mini-midline catheters, and medium-length venous catheters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheter Complications
- What is being tested?
- Mini Midline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 24 Jan 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The expected duration of IV fluids before placement is 1-4 weeks.
- Intravenous fluids are used only during hospitalization.
- The nature of the infused drugs is in accordance with the indications for peripheral venous catheters.
- Conscious and able to communicate normally.
- Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- History of radiation therapy, thrombosis, and trauma at the site of placement.
- Vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral venous catheters are the most commonly used vascular access devices in healthcare today, including indwelling needles, mini-midline catheters, and medium-length venous catheters. Peripheral venous catheters are required due to clinical needs for prescribed intravenous treatments, medications, surgical procedures, or diagnostics, such as computed tomography scans, etc. One study noted that more than 70% of hospitalized patients had indwelling needles placed. However, post-placement failure of indwelling needles occurs in 30%-50% of patients before completing treatment, unplanned catheter failure occurs in 69% of patients before completing treatment, and there is a 30%-60% risk of various complications. And patients are often subjected to repeat catheter placement, such as improper catheter placement or improperly entered medications. In addition, catheterization is prone to infectious and noninfectious complications, and the risk of phlebitis increases 4.4-fold when catheters are reintroduced.Tan et al. found that the average number of indwelling needle insertions per patient admission was 2.82, and therefore, approximately 44% of adult patients required more than one indwelling needle to complete IV therapy during their hospitalization. According to Helm et al, multiple insertions of indwelling needles per patient lead to unnecessary pain and anxiety, and multiple attempts per insertion further increase the risk of complications. These also lead to prolonged hospitalization, additional healthcare costs, pain, anxiety, and other adverse experiences.
Read the detailed description
Therefore, alternative vascular access is needed to meet the needs of patients. The mini midline catheter is a novel vascular access in recent years that is smaller in diameter, less invasive, and provides a lower complication rate during continuous IV administration. In addition, mini midline catheters can be left in place for 1-4 weeks, reducing the number of catheterizations. Mini-midline catheter placement sites include the forearm, anterior elbow fossa, or upper arm, and generally do not exceed the middle of the upper arm.20 The 2021 edition of the Infusion Therapy Standards of Practice (the "Standards") states that cephalic, vital, and median veins should be considered for placement of catheters, and that The standard indicates that the placement should be in the forearm, not exceeding the elbow socket, but the description is vague, and the level of evidence is Grade III. In addition to this, the domestic industry standards, the Technical Operation Code for Intravenous Therapy Nursing and related intravenous therapy guidelines do not provide clear standards and specifications for the use of mini-median catheters, and the selection of the optimal site is crucial to reducing complications.
Overseas studies have applied mini midline catheters to cardiac surgery and ICU patients, with the catheter placed in the upper arm, and the incidence of each complication is lower. In a study of mini midline catheter placement in children, the duration of retention was greater in the upper arm than in the forearm. Although several studies have reported differences in incidence and catheter retention time between the forearm and upper arm for mini midline catheters, few studies have directly compared the outcome of catheter placement in the upper arm or forearm, and there is very little direct experimental data on the relative advantages of the forearm versus the upper arm. Therefore, this study applies the mini midline catheter to patients and observes the application effect of different catheterization sites, aiming to provide a reference basis for patients to choose the optimal catheterization site, so as to reduce the occurrence of complications, prolong the catheter retention time, and alleviate the patient's pain.
- Conditions
- Catheter Complications
- Being tested
- Mini Midline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini MidlineDevice
The tube was placed in the upper arm in the test group and in the forearm in the control group. The veins were selected according to anatomical criteria (vein diameter and depth), and the puncture site was protected with a sterile cavity towel. The cannulation nurse wore sterile gloves and injected local anesthesia (1 mL of lidocaine) before venipuncture. Venipuncture was always performed using real-time ultrasound-guided visualization of the vein-guiding needle using an "out-of-plane" approach, and once the tip of the needle was visualized within the vein and the blood flowed back through the needle, a guidewire was introduced and the needle was removed. After the needle is removed, the cannula is advanced into the vein, the guidewire is removed, and the cannula is attached to an extension cord closed with a needleless connector.
| Study group | Role | What they receive |
|---|---|---|
| forearm | Experimental | Mini midline catheter forearm placement. Receives: Device: Mini Midline |
| upper arm | Other | Mini midline catheter upper arm placement Receives: Device: Mini Midline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related complications
Catheter-related complications included phlebitis, catheter-related thrombosis, catheter-related infection, catheter occlusion, catheter prolapse, blood leakage, and fluid leakage, and the incidence rate of each complication was the number of patients with the complication/total number of patients. The total incidence of catheter-related complications was the main outcome indicator, i.e., the number of patients with complications/the total number of patients, and the occurrence of one or more complications in the same patient was counted as one case.
Measured: during catheter indwelling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start9 Oct 2023
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
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 Catheter ComplicationsStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Linfang, Sir Run Run Shaw Hospital
- Investigators
- Linfang Zhao, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106659
- Sponsor's protocol ID
- 2023-802-01
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cano A, Ettcheto M, Espina M, Lopez-Machado A, Cajal Y, Rabanal F, Sanchez-Lopez E, Camins A, Garcia ML, Souto EB. State-of-the-art polymeric nanoparticles as promising therapeutic tools against human bacterial infections. J Nanobiotechnology. 2020 Oct 31;18(1):156. doi: 10.1186/s12951-020-00714-2.
PubMed 33129333
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes of Mini Midline Catheters With Different Placement Sites: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06106659
- Acronym / sponsor ID
- 2023-802-01
- Conditions
- Catheter Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 30 Oct 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.
Peripheral venous catheters are the most commonly used vascular access devices in healthcare today, including indwelling needles, mini-midline catheters, and medium-length venous catheters. Peripheral venous catheters are required due to clinical needs for prescribed intravenous treatments, medications, surgical procedures, or diagnostics, such as computed tomography scans, etc. One study noted that more than 70% of hospitalized patients had indwelling needles placed. However, post-placement failure of indwelling needles occurs in 30%-50% of patients before completing treatment, unplanned catheter failure occurs in 69% of patients before completing treatment, and there is a 30%-60% risk of various complications. And patients are often subjected to repeat catheter placement, such as improper catheter placement or improperly entered medications. In addition, catheterization is prone to infectious and noninfectious complications, and the risk of phlebitis increases 4.4-fold when catheters are reintroduced.Tan et al. found that the average number of indwelling needle insertions per patient admission was 2.82, and therefore, approximately 44% of adult patients required more than one indwelling needle to complete IV therapy during their hospitalization. According to Helm et al, multiple insertions of indwelling needles per patient lead to unnecessary pain and anxiety, and multiple attempts per insertion further increase the risk of complications. These also lead to prolonged hospitalization, additional healthcare costs, pain, anxiety, and other adverse experiences.
Detailed description
Therefore, alternative vascular access is needed to meet the needs of patients. The mini midline catheter is a novel vascular access in recent years that is smaller in diameter, less invasive, and provides a lower complication rate during continuous IV administration. In addition, mini midline catheters can be left in place for 1-4 weeks, reducing the number of catheterizations. Mini-midline catheter placement sites include the forearm, anterior elbow fossa, or upper arm, and generally do not exceed the middle of the upper arm.20 The 2021 edition of the Infusion Therapy Standards of Practice (the "Standards") states that cephalic, vital, and median veins should be considered for placement of catheters, and that The standard indicates that the placement should be in the forearm, not exceeding the elbow socket, but the description is vague, and the level of evidence is Grade III. In addition to this, the domestic industry standards, the Technical Operation Code for Intravenous Therapy Nursing and related intravenous therapy guidelines do not provide clear standards and specifications for the use of mini-median catheters, and the selection of the optimal site is crucial to reducing complications.
Overseas studies have applied mini midline catheters to cardiac surgery and ICU patients, with the catheter placed in the upper arm, and the incidence of each complication is lower. In a study of mini midline catheter placement in children, the duration of retention was greater in the upper arm than in the forearm. Although several studies have reported differences in incidence and catheter retention time between the forearm and upper arm for mini midline catheters, few studies have directly compared the outcome of catheter placement in the upper arm or forearm, and there is very little direct experimental data on the relative advantages of the forearm versus the upper arm. Therefore, this study applies the mini midline catheter to patients and observes the application effect of different catheterization sites, aiming to provide a reference basis for patients to choose the optimal catheterization site, so as to reduce the occurrence of complications, prolong the catheter retention time, and alleviate the patient's pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| forearm | Experimental | Device: Mini MidlineMini midline catheter forearm placement. |
| upper arm | Other | Device: Mini MidlineMini midline catheter upper arm placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The expected duration of IV fluids before placement is 1-4 weeks.
- Intravenous fluids are used only during hospitalization.
- The nature of the infused drugs is in accordance with the indications for peripheral venous catheters.
- Conscious and able to communicate normally.
- Voluntarily participate in this study and sign the informed consent form.
Key exclusion criteria (2 listed)
- History of radiation therapy, thrombosis, and trauma at the site of placement.
- Vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.
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 |
|---|---|---|
| Mini MidlineThe tube was placed in the upper arm in the test group and in the forearm in the control group. The veins were selected according to anatomical criteria (vein diameter and depth), and the puncture site was protected with a sterile cavity towel. The cannulation nurse wore sterile gloves and injected local anesthesia (1 mL of lidocaine) before venipuncture. Venipuncture was always performed using real-time ultrasound-guided visualization of the vein-guiding needle using an "out-of-plane" approach, and once the tip of the needle was visualized within the vein and the blood flowed back through the needle, a guidewire was introduced and the needle was removed. After the needle is removed, the cannula is advanced into the vein, the guidewire is removed, and the cannula is attached to an extension cord closed with a needleless connector. | Device | forearm, upper arm |
Primary outcome
Incidence of catheter-related complications
Time frame: during catheter indwelling procedure
Catheter-related complications included phlebitis, catheter-related thrombosis, catheter-related infection, catheter occlusion, catheter prolapse, blood leakage, and fluid leakage, and the incidence rate of each complication was the number of patients with the complication/total number of patients. The total incidence of catheter-related complications was the main outcome indicator, i.e., the number of patients with complications/the total number of patients, and the occurrence of one or more complications in the same patient was counted as one case.
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 11 Apr 2024.
- Background: PubMed 33129333Cano A, Ettcheto M, Espina M, Lopez-Machado A, Cajal Y, Rabanal F, Sanchez-Lopez E, Camins A, Garcia ML, Souto EB. State-of-the-art polymeric nanoparticles as promising therapeutic tools against human bacterial infections. J Nanobiotechnology. 2020 Oct 31;18(1):156. doi: 10.1186/s12951-020-00714-2.
- 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.
Linfang Zhao principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Midline in people with Catheter Complications, run by Sir Run Run Shaw Hospital at 1 site in China.
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 5 inclusion and 2 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 11 Apr 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 China. 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?
Incidence of catheter-related complications (time frame: during catheter indwelling procedure). 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 NCT06106659, 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 11 Apr 2024.