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| ID | Type | Description | Link |
|---|---|---|---|
| H-37285 | Other Grant/Funding Number | Society for Academic Emergency Medicine | |
| H-37285 | Other Grant/Funding Number | Bard Peripheral Vascular, Inc. |
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The study was stopped after a pause due to COVID-19 policies and new published evidence about the effectiveness of the interventon.
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| Name | Class |
|---|---|
| Society for Academic Emergency Medicine | OTHER |
| Bard Peripheral Vascular, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Active Comparator | Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length. |
|
| Midline Catheter | Active Comparator | Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Guided Peripheral IV Catheter | Device | Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours after device placement |
| Measure | Description | Time Frame |
|---|---|---|
| IV Catheter Insertion Time | The time it takes to insert the IV catheter will be documented in minutes for each study participant. | from catheter insertion |
| Total Number of Replacement Catheters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Pare, MD MHS RDMS | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36507736 | Derived | Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Guided Peripheral IV Catheter | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Only patients that received Ultrasound Guided Peripheral IV or Midline Catheter underwent analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who completed therapy within 72 hours were considered non-failure | Posted | Count of Participants | Participants | 72 hours after device placement |
|
Within 30 days of IV or Midline device placement
Adverse Event included device failure or required replacement.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound Guided Peripheral IV Catheter | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Failure | Surgical and medical procedures | Systematic Assessment | Device failure due to either pain, swelling, being dislodged, infiltration, or other failure such as inability to provide medications. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Pare, MD | Boston University School of Medicine | 6174144925 | Joseph.pare@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2018 | Mar 7, 2021 | Prot_SAP_000.pdf |
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randomized to one of two therapies, peripheral ultrasound IV or midline
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Given the devices are different we will not be able to mask.
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| Midline Catheter | Device | Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length. |
|
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).
| 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. | 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. | 72 hours after catheter insertion |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. |
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| Secondary | IV Catheter Insertion Time | The time it takes to insert the IV catheter will be documented in minutes for each study participant. | Time taken to place each device | Posted | Median | Inter-Quartile Range | minutes | from catheter insertion |
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| 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). | Number of additional IV (including Midline) catheters placed | Posted | Number | additional IV access devices | from catheter insertion up to 30 days |
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| Secondary | Catheter Related Costs | The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated. | Posted | Mean | Standard Deviation | US Dollars | from catheter insertion up to 30 days |
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| 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. | 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. | Posted | Count of Participants | Participants | 72 hours after catheter insertion |
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| 0 |
| 8 |
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | 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. | 0 | 8 | 0 | 8 | 1 | 8 |
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| No |
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