Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03655106
Other study ID # 2018-185
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date July 15, 2019

Study information

Verified date February 2020
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date July 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Standard Long IV 4.78 cm 20 g catheter
Standard Long IV 4.78 cm 20 g catheter
Ultra-Long IV 6.35 cm 20 g catheter
Ultra-Long IV 6.35 cm 20 g catheter

Locations

Country Name City State
United States Beaumont Hospitals Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 days
Secondary Thrombosis Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients 30 days
Secondary 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. 30 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04054128 - Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients Phase 4
Recruiting NCT05729321 - Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Recruiting NCT05334225 - Assessing the Knowledge and Self-confidence of Healthcare Workers to Perform Transurethral Catheterization: A Multicenter Survey
Completed NCT06106659 - Comparison of Clinical Outcomes of Mini Midline Catheters With Different Placement Sites: a Randomized Controlled Trial N/A
Not yet recruiting NCT06014099 - Research on the Application of Blood Collection Through Midline Catheters of Different Lengths N/A
Completed NCT03693755 - Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane N/A
Not yet recruiting NCT06019897 - Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection
Not yet recruiting NCT06149533 - Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients Phase 3
Completed NCT01465594 - Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy N/A
Recruiting NCT06001827 - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study N/A
Completed NCT04569474 - Peripheral IV Dressing and Phlebitis in Patients From Amazon N/A
Completed NCT05814887 - Reduction of Mechanical IV Complication Using a New Medical Device N/A
Recruiting NCT05741866 - Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) N/A
Completed NCT06312215 - Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services N/A
Recruiting NCT04359056 - Clinical Pharmacy for Patients With a PICC Line N/A
Not yet recruiting NCT05869877 - The PIV5Rights Safety and Quality Bundle N/A
Recruiting NCT04548713 - CLiCK in the Critical Care Unit N/A
Completed NCT04285775 - A Novel Device for Surveillance of Vascular Access Sites for Bleeding
Completed NCT05446987 - Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications N/A
Not yet recruiting NCT05354921 - Indwelling vs Intermittent Catheterization Pilot Study N/A