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Catheter ComplicationsNCT03655106

Ultrasound Guided Catheter Length Survivability

A study testing Standard Long IV 4.78 cm 20 g catheter and Ultra-Long IV 6.35 cm 20 g catheter in people with Catheter Complications, run by Corewell Health East at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In patients with difficult IV access, ultrasound-guided catheter insertion is a preferred technique. However, many peripheral catheters fail and must be replaced, adding extra pain and difficulty for the patient, and requiring more healthcare provider time to maintain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Catheter Complications
What is being tested?
Standard Long IV 4.78 cm 20 g catheter and Ultra-Long IV 6.35 cm 20 g catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteUnited States
Study dates
29 Oct 2018to 15 Jul 2019
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

  • Age 18 years or older
  • Self-reported difficult IV Access Patient and any one of the following:
  • Greater than 2 sticks in previous admission/hospital encounter
  • History of rescue vascular access device (such as US-guided IV, PICC line, midline, or CVC)
  • End-stage renal disease on dialysis
  • History of IV Drug Use
  • History of Sickle Cell Disease

Who cannot join

  • Age under 18 years old
  • Voluntary withdrawal or refusal to participate
  • Previous enrollment into the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Beaumont Hospitals

    Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: Standard vs Long IV Catheter Long-Term IV Survival Comparison

In patients with difficult IV access, ultrasound-guided catheter insertion is a preferred technique. However, many peripheral catheters fail and must be replaced, adding extra pain and difficulty for the patient, and requiring more healthcare provider time to maintain. In preliminary studies, we determined that catheters which extend further into the vein have a smaller failure rate. This study will compare two lengths of catheters to see if the longer catheters have better survival in a population of patients who have difficult IV access. Patients will be randomized to receive a standard length or extra-long venous catheter, which will be monitored daily for functionality during the patient's hospital course.

Read the detailed description

Patients with poor intravenous (IV) access present a daily challenge to emergency department (ED) practitioners. Placement of an ultrasound (US)-guided peripheral IV catheter in this patient population is a viable and safe option. Ultrasound-guided IVs are often the last recourse for IV access before resorting to more invasive procedures in patients with difficult access. Successful cannulation with US-guided IV occurs in more than 90% of cases compared with 25-35% with traditional IV placement in patients with difficult vascular access. Once cannulated, however, the failure rate of IV catheters placed under ultrasound guidance is concerning compared with traditional blind IV placement. Overall failure rates after successful IV cannulation for US-guided IVs is 45-56% when compared to traditional IV placement which is 19-25%. Because failure rate is high, it is important to approach insertions methodically to improve survival rates. A variable that may alter the survival of US-guided IVs that has not been studied is the length of catheter that resides in the vein. Currently the general accepted rule is that an "adequate" amount of the catheter should be in the vein to avoid failure of the catheter. Our preliminary data focused on defining this relationship. In our study, 100% of catheters failed in which less than 30% of the catheter was placed within the vein and no failures in those IVs in which at least 65% of the catheter was in the vein. This study was performed by the PI at Beaumont this past year and is published in Emergency Medicine Journal.

This study is a prospective randomized controlled study of catheter longevity comparing a 4.78 cm (1.88 in) catheter to a longer 6.35 cm (2.5 in) catheter. Subjects will consist of a convenience sample of patients with difficult IV access presenting to the Beaumont Hospitals emergency department that require US-guided IV access.

Standard of care is defined as use of a readily available 1.88 inch IV catheter that is used daily by emergency department personnel. Following consent, patients will be randomized to the control arm using the standard 4.78 cm catheter, or the experimental arm using a 6.35 cm catheter. All catheters are 20 gauge in diameter.

After patient enrollment, the insertion tech, nurse or physician who has been credentialed in ultrasound-guided vascular access will place catheters in study subjects. Staff are expected to attempt a minimum of 3 attempts before enlisting another provider for help.

After initial assessment, follow-up functionality of the catheter will be assessed every 24 hours by the research team as long as the patient is hospitalized, up to 30 days. Function of the catheter will be assessed daily by research staff. Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV.

Other data variables collected include: patient pertinent medical history, vitals, age, sex, cannulation success or failure, vein diameter, length of catheter in vein as well as % length of the catheter in the vein, angle of insertion, number of venous access attempts, time to IV insertion (tourniquet to tegaderm), location of IV insertion, medications infused or use for ionic contrast injection for computed tomography.

Being tested
Standard Long IV 4.78 cm 20 g catheter, Ultra-Long IV 6.35 cm 20 g catheter
Keywords
Ultrasound guided intravenous access, vascular access, extended dwell catheter, IV survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Long IV 4.78 cm 20 g catheterDevice

    Standard Long IV 4.78 cm 20 g catheter

  • Ultra-Long IV 6.35 cm 20 g catheterDevice

    Ultra-Long IV 6.35 cm 20 g catheter

Study groups in NCT03655106
Study groupRoleWhat they receive
Standard Long IV 4.78 cm 20 g catheterActive comparatorPlacement of Standard Long IV 4.78 cm 20 g catheter
Receives: Device: Standard Long IV 4.78 cm 20 g catheter
Ultra-Long IV 6.35 cm 20 g catheterExperimentalPlacement of Ultra-Long length IV 6.35 cm 20 g catheter
Receives: Device: Ultra-Long IV 6.35 cm 20 g catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of IV Survival

    Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff.

    Measured: 30 days

Secondary outcomes (2)
  1. Thrombosis

    Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients

    Measured: 30 days

  2. Infection

    Number of patient with infection as defined as the patient meeting the laboratory-confirmed bloodstream infection criteria as defined by the Centers for Disease Control.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start29 Oct 2018
  3. Primary completion15 Jul 2019
  4. Study completion15 Jul 2019

Resources

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 control parallel assignment
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03655106
Sponsor's protocol ID
2018-185
Status last verified
Feb 2020
First submitted
29 Aug 2018
Last updated
11 Mar 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bahl A, Hijazi M, Chen NW, Lachapelle-Clavette L, Price J. Ultralong Versus Standard Long Peripheral Intravenous Catheters: A Randomized Controlled Trial of Ultrasonographically Guided Catheter Survival. Ann Emerg Med. 2020 Aug;76(2):134-142. doi: 10.1016/j.annemergmed.2019.11.013. Epub 2020 Jan 16.

    PubMed 31955940

Questions about this trial

What is this clinical trial studying?

A study testing Standard Long IV 4.78 cm 20 g catheter and Ultra-Long IV 6.35 cm 20 g catheter in people with Catheter Complications, 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 7 inclusion and 3 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 Mar 2020. 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 11 Mar 2020). 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?

Duration of IV Survival (time frame: 30 days). 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 NCT03655106, 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 Mar 2020.

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