Superior Venous Access, Midline vs Ultrasound IVs

• Sponsor: Boston Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03440944
• Collaborator: Society for Academic Emergency Medicine (Other), Bard Peripheral Vascular, Inc. (Industry)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. Aim 2: To collect information to perform a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication; Ultrasound Therapy; Complications	Device: Ultrasound Guided Peripheral IV Catheter; Device: Midline Catheter	N/A

Detailed Description

This is a randomized controlled trial to determine if the midline catheter is superior to the ultrasound guided IV with respect to survival at 72 hours.

Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. There are several reasons why UGPIVs may fail. UGPIVs are shorter than midline catheters, and shorter catheters may fail due to infiltration which can be a result of malposition as well as having the catheter pull out of the vessel. It is being hypothesized that by using a midline catheter with a guidewire for placement with additional catheter length placed into the vessel, midlines will be superior to UGP\Vs with regards to survival time of the catheter. The investigators will assess catheter survival daily until 72 hours (when UGPIV are recommended to be changed). The total lifetime of the midline catheters will be recorded.

Aim 2: To perform a direct cost analysis of UGPIV against that of the midline catheter. This study will not be large enough to complete a robust cost effectiveness analysis to compare UGPIV to mid line catheters. As a part of this study the investigators will collect information including but not limited to: the number of catheters used for IVA attempts, time for placement of each device complications, and need for additional IVA during hospitalization.

Aim 3: For patients that remain hospitalized at 72 hours a satisfaction survey will be administered to determine patient experience and preference for the type of vascular access that they receive.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized to one of two therapies, peripheral ultrasound IV or midlinerandomized to one of two therapies, peripheral ultrasound IV or midline
• Masking: None (Open Label)
• Masking Description: Given the devices are different we will not be able to mask.
• Primary Purpose: Treatment
• Official Title: Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial
• Actual Study Start Date: Apr 23, 2018
• Actual Primary Completion Date: Jan 25, 2021
• Actual Study Completion Date: Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultrasound Guided Peripheral IV Catheter Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length.	Device: Ultrasound Guided Peripheral IV Catheter; Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
Active Comparator: Midline Catheter Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.	Device: Midline Catheter; Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.

Outcome Measures

Primary Outcome Measures

1. Device Failures Within 72 Hours [72 hours after device placement]

   Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care.

Secondary Outcome Measures

1. IV Catheter Insertion Time [from catheter insertion]

   The time it takes to insert the IV catheter will be documented in minutes for each study participant.

2. Total Number of Replacement Catheters [from catheter insertion up to 30 days]

   The total number of replacement IV catheters will be documented. This will be assessed based on each group (Ultrasound Guided Peripheral IV Catheter and Midline Catheter).

3. Catheter Related Costs [from catheter insertion up to 30 days]

   The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated.

4. Patient Satisfaction [72 hours after catheter insertion]

   Participant experience and satisfaction will be assessed with a short survey that will be given to participants who stay at least 72 hours after catheter insertion.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient at least 18 years of age being treated in the emergency department at Boston Medical Center

• Standard IVA cannot be obtained by two qualified ER staff

• Have an upper extremity (left or right arm) that can accept a deep venous IV

• Clinical team believes the patient is likely to require inpatient admission at time of needing IV access

• English speaking

• Able to provide consent

Exclusion Criteria:

• Patient expected to be discharged from the emergency department or discharged from the hospital within 1 nights stay.

• Prisoner

• Pregnancy

• Requires central line or midline catheter as an expected requirement of care

• Patients who are expected to require medication that is not approved for administration via a peripherally guided IV or midline as defined by hospital pharmacy guidelines.

• Patients known to have bacteremia or have a high suspicion of bacteremia

• The patient is known or is suspected to be allergic to materials contained in the device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston Medical Center
• Society for Academic Emergency Medicine
• Bard Peripheral Vascular, Inc.

Investigators

• Principal Investigator: Joseph Pare, MD MHS RDMS, Boston Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 29, 2018

More Information

Publications

None provided.

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT03440944
• Other Study ID Numbers: H-37285; H-37285; H-37285
• First Posted: Feb 22, 2018
• Last Update Posted: Apr 29, 2021
• Last Verified: Apr 1, 2021

• 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 Boston Medical Center: vascular access; midline cather; ultrasound guided IV

Study Results

Participant Flow

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Period Title: Overall Study
STARTED	9	9
COMPLETED	8	8
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter	Total
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.	Total of all reporting groups
Overall Participants	8	8	16
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 87.5%	7 87.5%	14 87.5%
>=65 years	1 12.5%	1 12.5%	2 12.5%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	42	53	49
Sex: Female, Male (Count of Participants)
Female	6 75%	7 87.5%	13 81.3%
Male	2 25%	1 12.5%	3 18.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 25%	2 12.5%
Not Hispanic or Latino	8 100%	6 75%	14 87.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 62.5%	5 62.5%	10 62.5%
White	3 37.5%	3 37.5%	6 37.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	8 100%	8 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	Device Failures Within 72 Hours
Description	Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care.
Time Frame	72 hours after device placement

Outcome Measure Data

Analysis Population Description

Patients who completed therapy within 72 hours were considered non-failure

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Measure Participants	8	8
Device Failure within 72 hours	6 75%	1 12.5%
No Device Failure within 72 hours	2 25%	7 87.5%

2. Secondary Outcome

Title	IV Catheter Insertion Time
Description	The time it takes to insert the IV catheter will be documented in minutes for each study participant.
Time Frame	from catheter insertion

Outcome Measure Data

Analysis Population Description

Time taken to place each device

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Measure Participants	8	8
Median (Inter-Quartile Range) [minutes]	9	17.5

3. Secondary Outcome

Title	Total Number of Replacement Catheters
Description	The total number of replacement IV catheters will be documented. This will be assessed based on each group (Ultrasound Guided Peripheral IV Catheter and Midline Catheter).
Time Frame	from catheter insertion up to 30 days

Outcome Measure Data

Analysis Population Description

Number of additional IV (including Midline) catheters placed

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Measure Participants	8	8
Number [additional IV access devices]	13	1

4. Secondary Outcome

Title	Catheter Related Costs
Description	The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated.
Time Frame	from catheter insertion up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Measure Participants	8	8
Mean (Standard Deviation) [US Dollars]	38.25 (21.95)	28.88 (4.68)

5. Secondary Outcome

Title	Patient Satisfaction
Description	Participant experience and satisfaction will be assessed with a short survey that will be given to participants who stay at least 72 hours after catheter insertion.
Time Frame	72 hours after catheter insertion

Outcome Measure Data

Analysis Population Description

Patients who stayed for 72 hours, preference to have midline over ultrasound guided peripheral IV catheter. Patients discharged prior to 72 hours of therapy are not included in the reported results. For the Midline Catheter arm only 3 participants stayed at least 72 hours; 5 participants did not complete the satisfaction survey.

Arm/Group Title	Ultrasound Guided Peripheral IV Catheter	Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Measure Participants	8	3
Prefer Midline	4 50%	3 37.5%
Unsure	3 37.5%	0 0%
No	1 12.5%	0 0%

Adverse Events

Time Frame	Within 30 days of IV or Midline device placement
Adverse Event Reporting Description	Adverse Event included device failure or required replacement.
Arm/Group Title	Ultrasound Guided Peripheral IV Catheter		Midline Catheter
Arm/Group Description	Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length. Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.		Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
All Cause Mortality
	Ultrasound Guided Peripheral IV Catheter		Midline Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Ultrasound Guided Peripheral IV Catheter		Midline Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Ultrasound Guided Peripheral IV Catheter		Midline Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/8 (75%)		1/8 (12.5%)
Surgical and medical procedures
Device Failure	6/8 (75%)	6	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.