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| Name | Class |
|---|---|
| 410 Medical | INDUSTRY |
| Atlanta Pediatric Device Consortium | OTHER |
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This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.
Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alaris Pump | No Intervention | Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. | |
| LifeFlow | Experimental | Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifeFlow | Device | The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration- Ultrasound Ordered to Completed | The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound. | From ED (Emergency Department) arrival to discharge/admission, less than 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total IV Fluid (mL) | Total IV fluid administered before ultrasound | From ED arrival to discharge/admission, less than 12 hours |
| Duration- Full Bladder | Fluid initiation and subjective sensation of full bladder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd P Chang, MD | Children's Hospital Los Angeles | Principal Investigator |
| Ara Festekjian, MD | Children's Hospital Los Angeles | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90026 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30106868 | Background | Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alaris Pump | Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. |
| FG001 | LifeFlow | Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alaris Pump | Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. |
| BG001 | LifeFlow | Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Duration- Ultrasound Ordered to Completed | The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound. | Posted | Mean | Standard Deviation | minutes | From ED (Emergency Department) arrival to discharge/admission, less than 12 hours |
|
6 months
All subjects are not at risk of death (as part of inclusion criteria)
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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 | Alaris Pump | Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Todd P Chang | Children's Hospital Los Angeles | 13233612109 | tochang@chla.usc.edu |
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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 | May 22, 2018 | Oct 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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|
| From ED arrival to discharge/admission, less than 12 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Total IV Fluid (mL) | Total IV fluid administered before ultrasound | Posted | Mean | Standard Deviation | mL | From ED arrival to discharge/admission, less than 12 hours |
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|
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| Secondary | Duration- Full Bladder | Fluid initiation and subjective sensation of full bladder | Posted | Mean | Standard Deviation | minutes | From ED arrival to discharge/admission, less than 12 hours |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | LifeFlow | Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D013568 | Pathological Conditions, Signs and Symptoms |