Dehydration, Dehydration in Children
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELifeFlow
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.
Sponsors
410 Medical
Atlanta Pediatric Device Consortium
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
1 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients older than 1 month and less than 18 years * Patients require IV crystalloid bolus fluids before a pelvic ultrasound
Exclusion criteria
* Known cardiac insufficiency or significant cardiac surgery * Hepatic insufficiency * Renal insufficiency * Any known fluid overload states (ascites, pulmonary edema) * On any diuretic or antihypertensive therapy * Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration- Ultrasound Ordered to Completed | From ED (Emergency Department) arrival to discharge/admission, less than 12 hours | The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total IV Fluid (mL) | From ED arrival to discharge/admission, less than 12 hours | Total IV fluid administered before ultrasound |
| Duration- Full Bladder | From ED arrival to discharge/admission, less than 12 hours | Fluid initiation and subjective sensation of full bladder |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alaris Pump Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. | 15 |
| 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | LifeFlow | Total | Alaris Pump |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 30 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.9 years STANDARD_DEVIATION 3.5 | 13.8 years STANDARD_DEVIATION 3.1 | 13.6 years STANDARD_DEVIATION 2.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alaris Pump | Duration- Ultrasound Ordered to Completed | 154.4 minutes | Standard Deviation 53.2 |
| LifeFlow | Duration- Ultrasound Ordered to Completed | 114.8 minutes | Standard Deviation 31.9 |
Secondary
Duration- Full Bladder
Fluid initiation and subjective sensation of full bladder
Time frame: From ED arrival to discharge/admission, less than 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alaris Pump | Duration- Full Bladder | 61.9 minutes | Standard Deviation 43.6 |
| LifeFlow | Duration- Full Bladder | 26.9 minutes | Standard Deviation 18.9 |
Secondary
Total IV Fluid (mL)
Total IV fluid administered before ultrasound
Time frame: From ED arrival to discharge/admission, less than 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alaris Pump | Total IV Fluid (mL) | 1612.9 mL | Standard Deviation 654.4 |
| LifeFlow | Total IV Fluid (mL) | 1482.7 mL | Standard Deviation 676.3 |