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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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.
- Conditions
- Catheter Complications
- 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 group | Role | What they receive |
|---|---|---|
| Standard Long IV 4.78 cm 20 g catheter | Active comparator | Placement 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 catheter | Experimental | Placement 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.
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)
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
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.
- First posted31 Aug 2018
- Study start29 Oct 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
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 Catheter ComplicationsStudies 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
- Randomized control parallel assignment
- Masking
- None (open label)
- Enrolment
- 270 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, Director of Emergency Ultrasound
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs Long IV Catheter Long-Term IV Survival Comparison
- ClinicalTrials.gov ID
- NCT03655106
- Acronym / sponsor ID
- 2018-185
- Conditions
- Catheter Complications
- Keywords
- Ultrasound guided intravenous access, vascular access, extended dwell catheter, IV survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Standard Long IV 4.78 cm 20 g catheter | Active comparator | Device: Standard Long IV 4.78 cm 20 g catheterPlacement of Standard Long IV 4.78 cm 20 g catheter |
| Ultra-Long IV 6.35 cm 20 g catheter | Experimental | Device: Ultra-Long IV 6.35 cm 20 g catheterPlacement of Ultra-Long length IV 6.35 cm 20 g catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- 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
Key exclusion criteria (3 listed)
- Age under 18 years old
- Voluntary withdrawal or refusal to participate
- Previous enrollment into the study
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 |
|---|---|---|
| Standard Long IV 4.78 cm 20 g catheterStandard Long IV 4.78 cm 20 g catheter | Device | Standard Long IV 4.78 cm 20 g catheter |
| Ultra-Long IV 6.35 cm 20 g catheterUltra-Long IV 6.35 cm 20 g catheter | Device | Ultra-Long IV 6.35 cm 20 g catheter |
Primary outcome
Duration of IV Survival
Time frame: 30 days
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.
2 secondary outcomes
Thrombosis
Time frame: 30 days
Infection
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31955940Bahl 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.
- 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.
Amit Bahl, MD principal investigator
Director of Emergency Ultrasound
1 site in 1 country: see every site and its status.
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.