IV Catheter-Related Infection or ComplicationNCT04409418
Blood Sampling Functionality of Extended Dwell Catheters
A study testing Extended dwell catheters in people with IV Catheter-Related Infection or Complication and Vascular Access Complication, run by Corewell Health East at 1 site in United States.
Trial summary
The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral Intravenous (IVs) especially during prolonged hospital stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Catheter-Related Infection or Complication, Vascular Access Complication, Peripheral Venous Access
- What is being tested?
- Extended dwell catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 30 Sep 2023
- 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
None listed.
Who cannot join
- Patients will be excluded if:
- Multiple lumens required
- Functional vascular access device exists proximal to the targeted area of insertion. This does not include superficial non-ultrasound guided peripheral IVs.
- Upper extremity cannot be accessed due to a coexisting medical condition
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection
The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral Intravenous (IVs) especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Read the detailed description
Many patients will require ongoing blood draws for laboratory testing while in the hospital and hospitals generally avoid using peripheral IVs for laboratory testing as it is associated with an increase in complications such as irritation and infiltration (where the IV medication or fluid will leak out of the vein and into the surrounding tissue). Therefore, patients are often required to have multiple needlesticks throughout their hospital stay which can lead to patient dissatisfaction and anxiety.
Extended dwell catheters (EDC) offer an alternative to peripheral IVs especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. While there is not a lot of evidence about how well these catheters will allow blood to be drawn, an EDC can be used to obtain blood for routine blood draws and potentially eliminate the need for additional needle sticks.
Eligible patients in this study will be randomized to two groups based on placement site: experimental group (forearm) or the control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. The research team will capture images on the ultrasound machine that is used for initial assessment of sites per routine care. If the vein is appropriate for cannulation based on these assessments, the Advance Practice Provider (APP) will insert the catheter. If the APP on the Vascular Access Team (VAT) has no adequate target visualized in the randomly selected site, the inserter may evaluate another site that is more suitable for cannulation. Functionality will be confirmed by ability to aspirate by drawing back into a syringe and then the catheter flushed with 5cc of normal saline without resistance. The site of insertion will be recorded and pertinent information will be collected similar to other catheter placements. Securement of the placed IV will be standardized between groups. Daily assessment of functionality (patency of the catheter) will be performed by the research team for the life of the catheter while hospitalized (up to 30 days).
- Conditions
- IV Catheter-Related Infection or Complication, Vascular Access Complication, Peripheral Venous Access
- Being tested
- Extended dwell catheters
- Keywords
- intravenous access, vascular access, IV survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended dwell cathetersDevice
EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Receives: Device: Extended dwell catheters |
| Control Group | Active comparator | Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Receives: Device: Extended dwell catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sampling Functionality
Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization.
Measured: During hospitalization, up to 30 days
Secondary outcomes (2)
Catheter Dwell Time/Survival
Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of hours until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization.
Measured: During hospitalization, up to 30 days
Thrombosis
The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation.
Measured: During hospitalization, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start23 Jun 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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.
- Other trials for IV Catheter-Related Infection or ComplicationStudies 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
- Model description
- Prospective, single-site, randomized
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Bahl, Corewell Health East
- Investigators
- Amit Bahl, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409418
- Sponsor's protocol ID
- 2020-053
- Status last verified
- Nov 2024
- First submitted
- 27 May 2020
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection
- ClinicalTrials.gov ID
- NCT04409418
- Acronym / sponsor ID
- 2020-053
- Conditions
- IV Catheter-Related Infection or Complication, Vascular Access Complication, Peripheral Venous Access
- Keywords
- intravenous access, vascular access, IV survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral Intravenous (IVs) especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Detailed description
Many patients will require ongoing blood draws for laboratory testing while in the hospital and hospitals generally avoid using peripheral IVs for laboratory testing as it is associated with an increase in complications such as irritation and infiltration (where the IV medication or fluid will leak out of the vein and into the surrounding tissue). Therefore, patients are often required to have multiple needlesticks throughout their hospital stay which can lead to patient dissatisfaction and anxiety.
Extended dwell catheters (EDC) offer an alternative to peripheral IVs especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. While there is not a lot of evidence about how well these catheters will allow blood to be drawn, an EDC can be used to obtain blood for routine blood draws and potentially eliminate the need for additional needle sticks.
Eligible patients in this study will be randomized to two groups based on placement site: experimental group (forearm) or the control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. The research team will capture images on the ultrasound machine that is used for initial assessment of sites per routine care. If the vein is appropriate for cannulation based on these assessments, the Advance Practice Provider (APP) will insert the catheter. If the APP on the Vascular Access Team (VAT) has no adequate target visualized in the randomly selected site, the inserter may evaluate another site that is more suitable for cannulation. Functionality will be confirmed by ability to aspirate by drawing back into a syringe and then the catheter flushed with 5cc of normal saline without resistance. The site of insertion will be recorded and pertinent information will be collected similar to other catheter placements. Securement of the placed IV will be standardized between groups. Daily assessment of functionality (patency of the catheter) will be performed by the research team for the life of the catheter while hospitalized (up to 30 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-site, randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Extended dwell cathetersIf the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. |
| Control Group | Active comparator | Device: Extended dwell cathetersControl group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Multiple lumens required
- Functional vascular access device exists proximal to the targeted area of insertion. This does not include superficial non-ultrasound guided peripheral IVs.
- Upper extremity cannot be accessed due to a coexisting medical condition
- Cognitively impaired
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 |
|---|---|---|
| Extended dwell cathetersEDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. | Device | Control Group, Experimental Group |
Primary outcome
Blood Sampling Functionality
Time frame: During hospitalization, up to 30 days
Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization.
2 secondary outcomes
Catheter Dwell Time/Survival
Time frame: During hospitalization, up to 30 days
Thrombosis
Time frame: During hospitalization, up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Amit Bahl, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended dwell catheters in people with IV Catheter-Related Infection or Complication and Vascular Access Complication, run by Corewell Health East 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 0 inclusion and 5 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 15 Nov 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 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 15 Nov 2024). 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?
Blood Sampling Functionality (time frame: During hospitalization, up to 30 days). 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 15 Nov 2024.