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| Name | Class |
|---|---|
| Analogic Corporation | INDUSTRY |
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Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard cannulation | No Intervention | The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions. | |
| Ultrasound guided cannulation | Active Comparator | The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonic Window ultrasound device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infiltration Due to Dialysis Access Cannulation | Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis. | 3 weeks from use of fistula |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Scale | Measured using a scale of 1-10 with 10 being the most severe pain | 3 weeks from use of fistula |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHS West pavilion dialysis center | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Cannulation | The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions. |
| FG001 | Ultrasound Guided Cannulation | The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Cannulation | The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions. |
| BG001 | Ultrasound Guided Cannulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Infiltration Due to Dialysis Access Cannulation | Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis. | Posted | Number | infiltration events | 3 weeks from use of fistula |
|
3 months
Study targeted at a specific intervention of needle insertion only.
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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 | Standard Cannulation | The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lalathaksha Kumbar | Henry Ford Hospital | 3136271761 | lkumbar1@hfhs.org |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Patient Pain Scale | Measured using a scale of 1-10 with 10 being the most severe pain | Posted | Mean | Standard Deviation | score on a scale | 3 weeks from use of fistula |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Ultrasound Guided Cannulation | The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula. Sonic Window ultrasound device | 0 | 5 | 0 | 5 | 0 | 5 |
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| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |