Ultrasound Therapy; Complications, Vascular Access Complication
Conditions
Keywords
vascular access, midline cather, ultrasound guided IV
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.
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.
Interventions
DEVICEUltrasound Guided Peripheral IV Catheter
Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
DEVICEMidline Catheter
Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Sponsors
Society for Academic Emergency Medicine
Bard Peripheral Vascular, Inc.
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Given the devices are different we will not be able to mask.
Intervention model description
randomized to one of two therapies, peripheral ultrasound IV or midline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter. | 8 |
| Midline 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. | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No Acceptable Vasculature | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Ultrasound Guided Peripheral IV Catheter | Midline Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 42 years | 53 years | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 6 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
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
Population: Patients who completed therapy within 72 hours were considered non-failure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Device Failures Within 72 Hours | Device Failure within 72 hours | 6 Participants |
| Ultrasound Guided Peripheral IV Catheter | Device Failures Within 72 Hours | No Device Failure within 72 hours | 2 Participants |
| Midline Catheter | Device Failures Within 72 Hours | Device Failure within 72 hours | 1 Participants |
| Midline Catheter | Device Failures Within 72 Hours | No Device Failure within 72 hours | 7 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Catheter Related Costs | 38.25 US Dollars | Standard Deviation 21.95 |
| Midline Catheter | Catheter Related Costs | 28.88 US Dollars | Standard Deviation 4.68 |
Secondary
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
Population: Time taken to place each device
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | IV Catheter Insertion Time | 9 minutes |
| Midline Catheter | IV Catheter Insertion Time | 17.5 minutes |
Secondary
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Patient Satisfaction | Prefer Midline | 4 Participants |
| Ultrasound Guided Peripheral IV Catheter | Patient Satisfaction | Unsure | 3 Participants |
| Ultrasound Guided Peripheral IV Catheter | Patient Satisfaction | No | 1 Participants |
| Midline Catheter | Patient Satisfaction | Prefer Midline | 3 Participants |
| Midline Catheter | Patient Satisfaction | Unsure | 0 Participants |
| Midline Catheter | Patient Satisfaction | No | 0 Participants |
Secondary
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
Population: Number of additional IV (including Midline) catheters placed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Total Number of Replacement Catheters | 13 additional IV access devices |
| Midline Catheter | Total Number of Replacement Catheters | 1 additional IV access devices |