Ultrasound Guided Catheter Length Survivability

• Sponsor: William Beaumont Hospitals (Other)
• Overall Status: Completed
• CT.gov ID: NCT03655106
• Collaborator: (none)
• Enrollment: 270
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 31.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Complications	Device: Standard Long IV 4.78 cm 20 g catheter; Device: Ultra-Long IV 6.35 cm 20 g catheter	N/A

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

• Study Type: Interventional
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized control parallel assignmentRandomized control parallel assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Standard vs Long IV Catheter Long-Term IV Survival Comparison
• Actual Study Start Date: Oct 29, 2018
• Actual Primary Completion Date: Jul 15, 2019
• Actual Study Completion Date: Jul 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Long IV 4.78 cm 20 g catheter Placement of Standard Long IV 4.78 cm 20 g catheter	Device: Standard Long IV 4.78 cm 20 g catheter; Standard Long IV 4.78 cm 20 g catheter
Experimental: Ultra-Long IV 6.35 cm 20 g catheter Placement of Ultra-Long length IV 6.35 cm 20 g catheter	Device: Ultra-Long IV 6.35 cm 20 g catheter; Ultra-Long IV 6.35 cm 20 g catheter

Outcome Measures

Primary Outcome Measures

1. Duration of IV Survival [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.

Secondary Outcome Measures

1. Thrombosis [30 days]

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

2. Infection [30 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Hospitals	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• William Beaumont Hospitals

Investigators

• Principal Investigator: Amit Bahl, MD, Director of Emergency Ultrasound

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 19, 2019

More Information

Publications

None provided.

• Responsible Party: Amit Bahl, Director of Emergency Ultrasound, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT03655106
• Other Study ID Numbers: 2018-185
• First Posted: Aug 31, 2018
• Last Update Posted: Mar 11, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Amit Bahl, Director of Emergency Ultrasound, William Beaumont Hospitals: Ultrasound guided intravenous access; vascular access; extended dwell catheter; IV survival

Study Results

Participant Flow

Arm/Group Title	Standard Long IV 4.78 cm 20 g Catheter	Ultra-Long IV 6.35 cm 20 g Catheter
Arm/Group Description	Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Period Title: Overall Study
STARTED	135	135
COMPLETED	126	131
NOT COMPLETED	9	4

Baseline Characteristics

Arm/Group Title	Standard Long IV 4.78 cm 20 g Catheter	Ultra-Long IV 6.35 cm 20 g Catheter	Total
Arm/Group Description	Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter	Total of all reporting groups
Overall Participants	126	131	257
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.2 (18.6)	60.2 (18.2)	59.2 (17.8)
Sex: Female, Male (Count of Participants)
Female	92 73%	92 70.2%	184 71.6%
Male	34 27%	39 29.8%	73 28.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	126 100%	131 100%	257 100%

Outcome Measures

1. Primary Outcome

Title	Duration of IV Survival
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Long IV 4.78 cm 20 g Catheter	Ultra-Long IV 6.35 cm 20 g Catheter
Arm/Group Description	Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Measure Participants	126	131
Median (95% Confidence Interval) [hours]	92	136

2. Secondary Outcome

Title	Thrombosis
Description	Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Long IV 4.78 cm 20 g Catheter	Ultra-Long IV 6.35 cm 20 g Catheter
Arm/Group Description	Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Measure Participants	126	131
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Infection
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Long IV 4.78 cm 20 g Catheter	Ultra-Long IV 6.35 cm 20 g Catheter
Arm/Group Description	Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Measure Participants	126	131
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	30 Days post IV catheter insertion
Adverse Event Reporting Description	Thrombosis was assessed based on upper extremity venous duplex results in symptomatic patients. Catheter related bloodstream infection was determined by the institutional Department of Epidemiology based on the definition of catheter related bloodstream infection provided by the Centers of Disease Control.
Arm/Group Title	Standard Long IV 4.78 cm 20 g Catheter		Ultra-Long IV 6.35 cm 20 g Catheter
Arm/Group Description	Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter		Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
All Cause Mortality
	Standard Long IV 4.78 cm 20 g Catheter		Ultra-Long IV 6.35 cm 20 g Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/131 (0%)
Serious Adverse Events
	Standard Long IV 4.78 cm 20 g Catheter		Ultra-Long IV 6.35 cm 20 g Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/131 (0%)
Other (Not Including Serious) Adverse Events
	Standard Long IV 4.78 cm 20 g Catheter		Ultra-Long IV 6.35 cm 20 g Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/131 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.