Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)NCT00279591
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
A study testing Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device in people with Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome), run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
- What is being tested?
- Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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.
- Mean respiratory rate >95th percentile for age, or >10% immature neutrophils.
- OR
Show all 9Show fewer
- Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.
- 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.
- -
Who cannot join
- Wrist circumference less than 11cm (minimum size for the Vasotrac device).
- Contractures of the wrists, not allowing correct placement of the Vasotrac device.
- Hematoma(s) located on both wrists from recent redial (<24hr) artery puncture.
- Patients likely to proceed to brain death per assessment of the referring physician.
- Patients being treated for malignant hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72205
About this study
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.
Read the 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).
- Being tested
- Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device, Standard of care blood pressure monitoring
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure deviceDevice
Continuous blood pressure monitoring of patients during med flight to hospital
Standard of care blood pressure monitoringDevice
Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Blood Pressure Monitoring | Active comparator | Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital. Receives: Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device |
| 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. Receives: Device: Standard of care blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to two weeks
Secondary outcomes (4)
Intensive Care Unit (ICU) Length of Stay
Measured: 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.
Total number of organ failure days is for each group as a whole.
Measured: 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.
Measured: Up to two weeks
Amount of Intravenous Fluid Resuscitation
Measured: At start of inter-facility transport, then every 15 minutes until arrival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJan 2008
Why it stopped: Lack of technical support and supplies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Stroud, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279591
- Sponsor's protocol ID
- 48082
- Other IDs
- CUMG Grant
- Status last verified
- Apr 2012
- First submitted
- 17 Jan 2006
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21173006
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
- ClinicalTrials.gov ID
- NCT00279591
- Acronym / sponsor ID
- 48082
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of technical support and supplies
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Posted 30 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Blood Pressure Monitoring | Active comparator | Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure devicePatients received continuous blood pressure monitoring the entire time they were in med flight to the hospital. |
| Standard of care blood pressure monitoring | Placebo comparator | Device: Standard of care blood pressure monitoringPatients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
- OR
- Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.
Key exclusion criteria (5 listed)
- Wrist circumference less than 11cm (minimum size for the Vasotrac device).
- Contractures of the wrists, not allowing correct placement of the Vasotrac device.
- Hematoma(s) located on both wrists from recent redial (<24hr) artery puncture.
- Patients likely to proceed to brain death per assessment of the referring physician.
- Patients being treated for malignant hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure deviceContinuous blood pressure monitoring of patients during med flight to hospital | Device | Continuous Blood Pressure Monitoring |
| Standard of care blood pressure monitoringPatients received the standard of care for blood pressure monitoring while en route to the hospital via med flight. | Device | Standard of care blood pressure monitoring |
Primary outcome
The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care
Time frame: 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.
4 secondary outcomes
Intensive Care Unit (ICU) Length of Stay
Time frame: 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.
Time frame: Up to two weeks
Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.
Time frame: Up to two weeks
Amount of Intravenous Fluid Resuscitation
Time frame: At start of inter-facility transport, then every 15 minutes until arrival.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21173006Stroud 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stroud, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device in people with Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome), run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care (time frame: Up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012.