Patient SatisfactionNCT05607238
Patient Perspective Midline Catheter in the Emergency Department
A study testing Ultrasound Guided Vascular Access - Midline catheter and Ultrasound Guided Vascular Access - peripheral IV in people with Patient Satisfaction and Patient Preference, run by Wake Forest University Health Sciences.
Trial summary
This study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Patient Preference
- What is being tested?
- Ultrasound Guided Vascular Access - Midline catheter and Ultrasound Guided Vascular Access - peripheral IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Sep 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
- Patient in the emergency department
- Failed 2 or more conventional attempts at vascular access *or*
- history of requiring US guided vascular access
- US Fellowship trained physician available
Who cannot join
- basilic vein access is contraindicated
- patient undergoing advanced resuscitation
About this study
Official title: Patient Perspective of Midline Catheters Versus Ultrasound Guided Peripheral IVs for Difficult IV Access in the ED
This study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters.
- Conditions
- Patient Satisfaction, Patient Preference
- Being tested
- Ultrasound Guided Vascular Access - Midline catheter, Ultrasound Guided Vascular Access - peripheral IV
- Keywords
- IV access, ultrasound guided IV, emergency care
- Medical subject headings
- Patient Satisfaction, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Vascular Access - Midline catheterProcedure or surgery
Ultrasound guided vascular access with a midline IV catheter
Ultrasound Guided Vascular Access - peripheral IVProcedure or surgery
Ultrasound guided vascular access with a peripheral IV catheter
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Peripheral IV | Active comparator | Placement of 4-5cm angiocath under ultrasound guidance Receives: Procedure: Ultrasound Guided Vascular Access - peripheral IV |
| Ultrasound Guided Midline Catheter | Experimental | Placement of 10-15cm midline catheter under ultrasound guidance Receives: Procedure: Ultrasound Guided Vascular Access - Midline catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction with Procedure
Score describes a patient's satisfaction with a healthcare decision. It measures satisfaction across 6 domains via 6 questions scored on a 5 point scale. Score ranges from 6 to 30. A low score signifies dissatisfaction, a high score signifies high satisfaction.
Measured: Immediately after procedure/Baseline
Patient Satisfaction with Procedure
Score describes a patient's satisfaction with a healthcare decision. It measures satisfaction across 6 domains via 6 questions scored on a 5 point scale. Score ranges from 6 to 30. A low score signifies dissatisfaction, a high score signifies high satisfaction.
Measured: At 48 Hours Post Baseline
Secondary outcomes (10)
Number of needle punctures in a 24 hour period (patient reported)
Measured: up to 48 hours
Duration of Successful Access
IV/Cath dwell time in hours
Measured: up to 48 hours
Number of Needle Sticks
Prior to gaining successful access
Measured: up to 48 hours
Number of Insertion Attempts
For ultrasound guided access
Measured: up to 48 hours
Emergency Department (ED) Length of Stay
in hours
Measured: up to 48 hours
Hospital Length of Stay
in hours
Measured: up to 48 hours
Patient Satisfaction
this is a single question measuring satisfaction with the intervention overall on a Likert Scale 1-10,
Measured: immediately post intervention/baseline and at 48 hours past baseline
Number of Insertion Related Complications
Includes failed attempts, arterial punctures, infiltrations, hematoma formations
Measured: up to 48 hours
Number of Dwell Related Complications
Includes inability to flush, catheter dislodgement, leakage around the catheter site, insertion site erythema, insertion site pain, drainage from catheter, edema, ecchymosis, superficial thrombosis, Deep vein thrombosis (DVT), line associated infection, vesicant extravasation, skin necrosis, neurovascular injury, arterial injury
Measured: up to 48 hours
Time to Access
minutes from procedure start to procedure completion
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startMay 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: One of the key physicians is leaving the institution and other delays have put us behind our timeline. We do not intend to proceed with the trial at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Casey Glass, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607238
- Sponsor's protocol ID
- IRB00089914
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspective of Midline Catheters Versus Ultrasound Guided Peripheral IVs for Difficult IV Access in the ED
- ClinicalTrials.gov ID
- NCT05607238
- Acronym / sponsor ID
- IRB00089914
- Conditions
- Patient Satisfaction, Patient Preference
- Keywords
- IV access, ultrasound guided IV, emergency care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the key physicians is leaving the institution and other delays have put us behind our timeline. We do not intend to proceed with the trial at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Nov 2022 (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 study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Peripheral IV | Active comparator | Procedure: Ultrasound Guided Vascular Access - peripheral IVPlacement of 4-5cm angiocath under ultrasound guidance |
| Ultrasound Guided Midline Catheter | Experimental | Procedure: Ultrasound Guided Vascular Access - Midline catheterPlacement of 10-15cm midline catheter under ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient in the emergency department
- Failed 2 or more conventional attempts at vascular access *or*
- history of requiring US guided vascular access
- US Fellowship trained physician available
Key exclusion criteria (2 listed)
- basilic vein access is contraindicated
- patient undergoing advanced resuscitation
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 Vascular Access - Midline catheterUltrasound guided vascular access with a midline IV catheter | Procedure or surgery | Ultrasound Guided Midline Catheter |
| Ultrasound Guided Vascular Access - peripheral IVUltrasound guided vascular access with a peripheral IV catheter | Procedure or surgery | Ultrasound Guided Peripheral IV |
Primary outcome
Patient Satisfaction with Procedure
Time frame: Immediately after procedure/Baseline
Score describes a patient's satisfaction with a healthcare decision. It measures satisfaction across 6 domains via 6 questions scored on a 5 point scale. Score ranges from 6 to 30. A low score signifies dissatisfaction, a high score signifies high satisfaction.
Patient Satisfaction with Procedure
Time frame: At 48 Hours Post Baseline
Score describes a patient's satisfaction with a healthcare decision. It measures satisfaction across 6 domains via 6 questions scored on a 5 point scale. Score ranges from 6 to 30. A low score signifies dissatisfaction, a high score signifies high satisfaction.
10 secondary outcomes
Number of needle punctures in a 24 hour period (patient reported)
Time frame: up to 48 hours
Duration of Successful Access
Time frame: up to 48 hours
Number of Needle Sticks
Time frame: up to 48 hours
Number of Insertion Attempts
Time frame: up to 48 hours
Emergency Department (ED) Length of Stay
Time frame: up to 48 hours
Hospital Length of Stay
Time frame: up to 48 hours
Patient Satisfaction
Time frame: immediately post intervention/baseline and at 48 hours past baseline
Number of Insertion Related Complications
Time frame: up to 48 hours
Number of Dwell Related Complications
Time frame: up to 48 hours
Time to Access
Time frame: up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- 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.
Casey Glass, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Vascular Access - Midline catheter and Ultrasound Guided Vascular Access - peripheral IV in people with Patient Satisfaction and Patient Preference, run by Wake Forest University Health Sciences.
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 4 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: withdrawn, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Patient Satisfaction with Procedure (time frame: Immediately after procedure/Baseline). The study lists 2 primary outcomes in all. 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 2 Jun 2023.