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Urine output and urine drain line pressure were monitored while urine was drained into either:
The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test- Accuryn Urine Output Monitor | Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. |
| |
| Control- Critcore Urine Output Monitor | A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accuryn | Device | Accuryn is a novel electronic urine output monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine Output of SOC Device Versus Accuryn | Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube. | 2 - 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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ICU patient that needs a Foley catheter
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| Name | Affiliation | Role |
|---|---|---|
| George Kramer | UTMB | Principal Investigator |
| Bruce Friedman | Joseph M. Stills Burn Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Burn Center at Doctors Hospital | Augusta | Georgia | 30909 | United States | ||
| The University of Texas Medical Branch (UTMBP) |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test- Accuryn Urine Output Monitor | Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Accuryn: Accuryn is a novel electronic urine output monitor |
| FG001 | Control- Critcore Urine Output Monitor | A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test- Accuryn Urine Output Monitor | Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Accuryn: Accuryn is a novel electronic urine output monitor |
| BG001 | Control- Critcore Urine Output Monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Urine Output of SOC Device Versus Accuryn | Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube. | Posted | Number | 95% Confidence Interval | Patients with airlocks | 2 - 5 days |
|
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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 | Test- Accuryn Urine Output Monitor | Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Accuryn: Accuryn is a novel electronic urine output monitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devyani Nanduri | Theranova, LLC | 415-926-8616 | dnanduri@theranova.com |
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| ID | Term |
|---|---|
| D009846 | Oliguria |
| D011141 | Polyuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Galveston |
| Texas |
| 77555 |
| United States |
A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control- Critcore Urine Output Monitor | A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored. | 0 | 0 | 0 | 0 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |