Vascular Access ComplicationNCT03440944
Superior Venous Access, Midline vs Ultrasound IVs
A study testing Ultrasound Guided Peripheral IV Catheter and Midline Catheter in people with Vascular Access Complication and Ultrasound Therapy; Complications, run by Boston Medical Center at 1 site in United States.
Trial summary
Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Ultrasound Therapy; Complications
- What is being tested?
- Ultrasound Guided Peripheral IV Catheter and Midline Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 25 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient at least 18 years of age being treated in the emergency department at Boston Medical Center
- Standard IVA cannot be obtained by two qualified ER staff
- Have an upper extremity (left or right arm) that can accept a deep venous IV
- Clinical team believes the patient is likely to require inpatient admission at time of needing IV access
- English speaking
- Able to provide consent
Who cannot join
- Patient expected to be discharged from the emergency department or discharged from the hospital within 1 nights stay.
- Prisoner
- Pregnancy
- Requires central line or midline catheter as an expected requirement of care
- Patients who are expected to require medication that is not approved for administration via a peripherally guided IV or midline as defined by hospital pharmacy guidelines.
- Patients known to have bacteremia or have a high suspicion of bacteremia
- The patient is known or is suspected to be allergic to materials contained in the device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial
Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. Aim 2: To collect information to perform a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient satisfaction.
Read the detailed description
This is a randomized controlled trial to determine if the midline catheter is superior to the ultrasound guided IV with respect to survival at 72 hours.
Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. There are several reasons why UGPIVs may fail. UGPIVs are shorter than midline catheters, and shorter catheters may fail due to infiltration which can be a result of malposition as well as having the catheter pull out of the vessel. It is being hypothesized that by using a midline catheter with a guidewire for placement with additional catheter length placed into the vessel, midlines will be superior to UGP\Vs with regards to survival time of the catheter. The investigators will assess catheter survival daily until 72 hours (when UGPIV are recommended to be changed). The total lifetime of the midline catheters will be recorded.
Aim 2: To perform a direct cost analysis of UGPIV against that of the midline catheter. This study will not be large enough to complete a robust cost effectiveness analysis to compare UGPIV to mid line catheters. As a part of this study the investigators will collect information including but not limited to: the number of catheters used for IVA attempts, time for placement of each device complications, and need for additional IVA during hospitalization.
Aim 3: For patients that remain hospitalized at 72 hours a satisfaction survey will be administered to determine patient experience and preference for the type of vascular access that they receive.
- Being tested
- Ultrasound Guided Peripheral IV Catheter, Midline Catheter
- Keywords
- vascular access, midline cather, ultrasound guided IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Peripheral IV CatheterDevice
Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
Midline CatheterDevice
Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Active comparator | Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length. Receives: Device: Ultrasound Guided Peripheral IV Catheter |
| Midline Catheter | Active comparator | Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Receives: Device: Midline Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Failures Within 72 Hours
Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care.
Measured: 72 hours after device placement
Secondary outcomes (4)
IV Catheter Insertion Time
The time it takes to insert the IV catheter will be documented in minutes for each study participant.
Measured: from catheter insertion
Total Number of Replacement Catheters
The total number of replacement IV catheters will be documented. This will be assessed based on each group (Ultrasound Guided Peripheral IV Catheter and Midline Catheter).
Measured: from catheter insertion up to 30 days
Catheter Related Costs
The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated.
Measured: from catheter insertion up to 30 days
Patient Satisfaction
Participant experience and satisfaction will be assessed with a short survey that will be given to participants who stay at least 72 hours after catheter insertion.
Measured: 72 hours after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start23 Apr 2018
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Why it stopped: The study was stopped after a pause due to COVID-19 policies and new published evidence about the effectiveness of the interventon.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized to one of two therapies, peripheral ultrasound IV or midline
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Academic Emergency Medicine, Bard Peripheral Vascular, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph Pare, MD MHS RDMS, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440944
- Sponsor's protocol ID
- H-37285
- Other IDs
- H-37285, H-37285
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2018
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
PubMed 36507736
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03440944
- Acronym / sponsor ID
- H-37285
- Keywords
- vascular access, midline cather, ultrasound guided IV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped after a pause due to COVID-19 policies and new published evidence about the effectiveness of the interventon.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Society for Academic Emergency Medicine, Bard Peripheral Vascular, Inc.
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. Aim 2: To collect information to perform a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient satisfaction.
Detailed description
This is a randomized controlled trial to determine if the midline catheter is superior to the ultrasound guided IV with respect to survival at 72 hours.
Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. There are several reasons why UGPIVs may fail. UGPIVs are shorter than midline catheters, and shorter catheters may fail due to infiltration which can be a result of malposition as well as having the catheter pull out of the vessel. It is being hypothesized that by using a midline catheter with a guidewire for placement with additional catheter length placed into the vessel, midlines will be superior to UGP\Vs with regards to survival time of the catheter. The investigators will assess catheter survival daily until 72 hours (when UGPIV are recommended to be changed). The total lifetime of the midline catheters will be recorded.
Aim 2: To perform a direct cost analysis of UGPIV against that of the midline catheter. This study will not be large enough to complete a robust cost effectiveness analysis to compare UGPIV to mid line catheters. As a part of this study the investigators will collect information including but not limited to: the number of catheters used for IVA attempts, time for placement of each device complications, and need for additional IVA during hospitalization.
Aim 3: For patients that remain hospitalized at 72 hours a satisfaction survey will be administered to determine patient experience and preference for the type of vascular access that they receive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized to one of two therapies, peripheral ultrasound IV or midline
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Active comparator | Device: Ultrasound Guided Peripheral IV CatheterPatients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length. |
| Midline Catheter | Active comparator | Device: Midline CatheterPatients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient at least 18 years of age being treated in the emergency department at Boston Medical Center
- Standard IVA cannot be obtained by two qualified ER staff
- Have an upper extremity (left or right arm) that can accept a deep venous IV
- Clinical team believes the patient is likely to require inpatient admission at time of needing IV access
- English speaking
Key exclusion criteria (7 listed)
- Patient expected to be discharged from the emergency department or discharged from the hospital within 1 nights stay.
- Prisoner
- Pregnancy
- Requires central line or midline catheter as an expected requirement of care
- Patients who are expected to require medication that is not approved for administration via a peripherally guided IV or midline as defined by hospital pharmacy guidelines.
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 |
|---|---|---|
| Ultrasound Guided Peripheral IV CatheterPatients randomized to this arm will receive an ultrasound guided peripheral IV catheter. | Device | Ultrasound Guided Peripheral IV Catheter |
| Midline CatheterPatients randomized to this group will receive a midline catheter. The catheter is 10cm in length. | Device | Midline Catheter |
Primary outcome
Device Failures Within 72 Hours
Time frame: 72 hours after device placement
Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care.
4 secondary outcomes
IV Catheter Insertion Time
Time frame: from catheter insertion
Total Number of Replacement Catheters
Time frame: from catheter insertion up to 30 days
Catheter Related Costs
Time frame: from catheter insertion up to 30 days
Patient Satisfaction
Time frame: 72 hours after catheter insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36507736Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
- 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.
Joseph Pare, MD MHS RDMS principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Peripheral IV Catheter and Midline Catheter in people with Vascular Access Complication and Ultrasound Therapy; Complications, run by Boston Medical Center at 1 site in United States.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Apr 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Device Failures Within 72 Hours (time frame: 72 hours after device 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 NCT03440944, 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 29 Apr 2021.