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| ID | Type | Description | Link |
|---|---|---|---|
| CUMG Grant |
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Lack of technical support and supplies
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A randomized controlled trial compared the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noninvasive blood pressure.
94 transported patients were randomized to a control arm, monitored with a standard oscillometric blood pressure device (Dinamap), or an experimental arm, monitored with a near-continuous, noninvasive blood pressure device (Vasotrac).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Blood Pressure Monitoring | Active Comparator | Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital. |
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| Standard of care blood pressure monitoring | Placebo Comparator | Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device | Device | Continuous blood pressure monitoring of patients during med flight to hospital |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall. | Up to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit (ICU) Length of Stay | Up to two weeks | |
| Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure. |
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Inclusion Criteria:
Pediatric patients transported by Angel One to Arkansas Children's Hospital.
Age Group: 1 year - 17 years AND
Patients at risk of developing SIRS (Systemic Inflammatory Response Syndrome), according to the criteria below.
i. The presence of at least two of the following four criteria (one of which must be abnormal temperature or leukocyte count): A. Core temperature of >38.5 C or <36 C. B. Tachycardia, defined as mean heart rate >95th percentile for age in absence of external stimulus, chronic drugs, or painful stimuli.
C. Mean respiratory rate >95th percentile for age, or >10% immature neutrophils.
OR
Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.
i. Glasgow Coma scale <15 with one or more of the following: A. Mass lesion or cerebral edema on CT or MRI scan. B. Post-Traumatic Seizure. C. Multiple Trauma. D. Focal Neurologic Signs. E. Intubation for control of suspected intracranial hypertension.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Stroud, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21173006 | Result | Stroud MH, Prodhan P, Moss M, Fiser R, Schexnayder S, Anand K. Enhanced monitoring improves pediatric transport outcomes: a randomized controlled trial. Pediatrics. 2011 Jan;127(1):42-8. doi: 10.1542/peds.2010-1336. Epub 2010 Dec 20. |
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Pediatric interfacility helicopter transport patients between May 2006 and June 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Oscillometric Blood Pressure Monitoring |
| FG001 | Intervention Group | Near Continuous Blood Pressure Monitoring |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard of care blood pressure monitoring | Device | Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight. |
|
Total number of organ failure days is for each group as a whole.
| Up to two weeks |
| Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness. | Up to two weeks |
| Amount of Intravenous Fluid Resuscitation | At start of inter-facility transport, then every 15 minutes until arrival. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Oscillometric Blood Pressure Monitoring |
| BG001 | Intervention Group | Near Continuous Blood Pressure Monitoring |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall. | Intention to Treat | Posted | Mean | Standard Deviation | days | Up to two weeks |
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| Secondary | Intensive Care Unit (ICU) Length of Stay | Posted | Mean | Standard Deviation | days | Up to two weeks |
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| Secondary | Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure. | Total number of organ failure days is for each group as a whole. | ITT | Posted | Number | Days | Up to two weeks | Days | Participants |
|
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| Secondary | Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness. | This is the total number of participants analyzed for the intervention group and the control group and the total number of days analyzed overall for the intervention group and the control group. | Posted | Mean | Standard Deviation | units on a scale | Up to two weeks | Days | Participants |
|
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| Secondary | Amount of Intravenous Fluid Resuscitation | Posted | Mean | Standard Deviation | ml/kg | At start of inter-facility transport, then every 15 minutes until arrival. |
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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 | Control Group | Oscillometric Blood Pressure Monitoring | 0 | 48 | 0 | 48 | ||
| EG001 | Intervention Group | Near Continuous Blood Pressure Monitoring | 0 | 46 | 0 | 46 |
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Small Sample Size. Halted prior to projected enrollment secondary to lack of technical support and supplies for near continuous BP measuring device.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Stroud | University of Arkansas for Medical Sciences | 501-364-1861 | StroudMichaelH@uams.edu |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| >=65 years |
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| Male |
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| Days |
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| Days |
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