Ultrasound Guided Catheter Length Survivability

NCT ID: NCT03655106

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2019-07-15

Brief 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. 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.

Conditions

Catheter Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Long IV 4.78 cm 20 g catheter

Placement of Standard Long IV 4.78 cm 20 g catheter

Group Type: ACTIVE_COMPARATOR

Standard Long IV 4.78 cm 20 g catheter

Intervention Type: DEVICE

Standard Long IV 4.78 cm 20 g catheter

Ultra-Long IV 6.35 cm 20 g catheter

Placement of Ultra-Long length IV 6.35 cm 20 g catheter

Group Type: EXPERIMENTAL

Ultra-Long IV 6.35 cm 20 g catheter

Intervention Type: DEVICE

Ultra-Long IV 6.35 cm 20 g catheter

Interventions

Standard Long IV 4.78 cm 20 g catheter

Standard Long IV 4.78 cm 20 g catheter

Intervention Type: DEVICE

Ultra-Long IV 6.35 cm 20 g catheter

Ultra-Long IV 6.35 cm 20 g catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Age under 18 years old

• Voluntary withdrawal or refusal to participate
• Previous enrollment into the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Amit Bahl

Director of Emergency Ultrasound

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Bahl, MD

Role: PRINCIPAL_INVESTIGATOR

Director of Emergency Ultrasound

Locations

Beaumont Hospitals

Royal Oak, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31955940 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-185

Identifier Type: -

Identifier Source: org_study_id