An interventional study of Ultrasound Guided Peripheral IV Catheter and Midline Catheter in Vascular Access Complication and Ultrasound Therapy; Complications, sponsored by Boston Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Device: Midline Catheter
Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Device Failures Within 72 Hours
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
IV Catheter Insertion Time
The time it takes to insert the IV catheter will be documented in minutes for each study participant.
Time frame: from catheter insertion
Total Number of Replacement Catheters
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
Catheter Related Costs
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
Patient Satisfaction
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
| Milestone | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| Started | 9 | 9 |
| Completed | 8 | 8 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: No acceptable vasculature | 0 | 1 |
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.
| Participants | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| Device Failure within 72 hours | 6 | 1 |
| No Device Failure within 72 hours | 2 | 7 |
The time it takes to insert the IV catheter will be documented in minutes for each study participant.
| minutes | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| IV Catheter Insertion Time | 9 (7 to 13) | 17.5 (14 to 25) |
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).
| additional IV access devices | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| Total Number of Replacement Catheters | 13 | 1 |
The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated.
| US Dollars | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| Catheter Related Costs | 38.25 ± 21.95 | 28.88 ± 4.68 |
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.
| Participants | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| Prefer Midline | 4 | 3 |
| Unsure | 3 | 0 |
| No | 1 | 0 |
Collected over Within 30 days of IV or Midline device placement. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| Midline Catheter | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Event | Ultrasound Guided Peripheral IV Catheter | Midline Catheter |
|---|---|---|
| Device FailureSurgical and medical procedures | 6/8 | 1/8 |
Only patients that received Ultrasound Guided Peripheral IV or Midline Catheter underwent analysis.
| Age, Categorical(Participants) | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 14 |
| >=65 years | 1 | 1 | 2 |
| Age, Continuous(years) | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| Median | 42 (36 to 58) | 53 (43 to 62) | 49 (38 to 60) |
| Sex: Female, Male(Participants) | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 8 | 6 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 3 | 3 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
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