Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEContinuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
Continuous blood pressure monitoring of patients during med flight to hospital
Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients transported by Angel One to Arkansas Children's Hospital. 2. Age Group: 1 year - 17 years AND 3. 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 4. 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. \-
Exclusion criteria
1. Wrist circumference less than 11cm (minimum size for the Vasotrac device). 2. Contractures of the wrists, not allowing correct placement of the Vasotrac device. 3. Hematoma(s) located on both wrists from recent redial (\<24hr) artery puncture. 4. Patients likely to proceed to brain death per assessment of the referring physician. 5. Patients being treated for malignant hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | Up to two weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Up to two weeks | Total number of organ failure days is for each group as a whole. |
| Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | Up to two weeks | 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. |
| Amount of Intravenous Fluid Resuscitation | At start of inter-facility transport, then every 15 minutes until arrival. | — |
Countries
United States
Participant flow
Recruitment details
Pediatric interfacility helicopter transport patients between May 2006 and June 2007.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Oscillometric Blood Pressure Monitoring | 48 |
| Intervention Group Near Continuous Blood Pressure Monitoring | 46 |
| Total | 94 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 48 Participants | 94 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 | 6.5 years STANDARD_DEVIATION 4.6 | 8.5 years STANDARD_DEVIATION 5.6 | 7.5 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment United States | 46 participants | 48 participants | 94 participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 30 Participants | 28 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 46 |
| serious Total, serious adverse events | 0 / 48 | 0 / 46 |
Outcome results
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.
Time frame: Up to two weeks
Population: Intention to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | 10.0 days | Standard Deviation 13.8 |
| Intervention Group | The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | 5.4 days | Standard Deviation 4.6 |
Secondary
Amount of Intravenous Fluid Resuscitation
Time frame: At start of inter-facility transport, then every 15 minutes until arrival.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Amount of Intravenous Fluid Resuscitation | 19.8 ml/kg | Standard Deviation 22.2 |
| Intervention Group | Amount of Intravenous Fluid Resuscitation | 9.9 ml/kg | Standard Deviation 9.9 |
Secondary
Intensive Care Unit (ICU) Length of Stay
Time frame: Up to two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Intensive Care Unit (ICU) Length of Stay | 3.7 days | Standard Deviation 4.5 |
| Intervention Group | Intensive Care Unit (ICU) Length of Stay | 2.8 days | Standard Deviation 4.8 |
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.
Time frame: Up to two weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | 22.4 units on a scale | Standard Deviation 10.1 |
| Intervention Group | Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | 23.9 units on a scale | Standard Deviation 10.1 |
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.
Time frame: Up to two weeks
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | 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. | 18 Days |
| Intervention Group | 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. | 32 Days |
p-value: 0.03Fisher Exact