Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport

• Sponsor: University of Arkansas (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00279591
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)	Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device; Device: Standard of care blood pressure monitoring	N/A

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

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Continuous Blood Pressure Monitoring Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.	Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device; Continuous blood pressure monitoring of patients during med flight to hospital
Placebo Comparator: Standard of care blood pressure monitoring Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital.	Device: Standard of care blood pressure monitoring; Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Intensive Care Unit (ICU) Length of Stay [Up to two weeks]

2. 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.

3. 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.

4. Amount of Intravenous Fluid Resuscitation [At start of inter-facility transport, then every 15 minutes until arrival.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. 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.

1. Mean respiratory rate >95th percentile for age, or >10% immature neutrophils.

OR

1. Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

• Principal Investigator: Michael Stroud, MD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT00279591
• Other Study ID Numbers: 48082; CUMG Grant
• First Posted: Jan 19, 2006
• Last Update Posted: Apr 30, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Systemic Inflammatory Response Syndrome

Study Results

Participant Flow

Recruitment Details	Pediatric interfacility helicopter transport patients between May 2006 and June 2007.

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Oscillometric Blood Pressure Monitoring	Near Continuous Blood Pressure Monitoring
Period Title: Overall Study
STARTED	48	46
COMPLETED	48	46
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Intervention Group	Total
Arm/Group Description	Oscillometric Blood Pressure Monitoring	Near Continuous Blood Pressure Monitoring	Total of all reporting groups
Overall Participants	48	46	94
Age (Count of Participants)
<=18 years	48 100%	46 100%	94 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.5 (5.6)	6.5 (4.6)	7.5 (5.1)
Sex: Female, Male (Count of Participants)
Female	20 41.7%	16 34.8%	36 38.3%
Male	28 58.3%	30 65.2%	58 61.7%
Region of Enrollment (participants) [Number]
United States	48 100%	46 100%	94 100%

Outcome Measures

1. Primary Outcome

Title	The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care
Description	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

Outcome Measure Data

Analysis Population Description

Intention to Treat

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Oscillometric Blood Pressure Monitoring	Near Continuous Blood Pressure Monitoring
Measure Participants	48	46
Mean (Standard Deviation) [days]	10.0 (13.8)	5.4 (4.6)

2. Secondary Outcome

Title	Intensive Care Unit (ICU) Length of Stay
Time Frame	Up to two weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Oscillometric Blood Pressure Monitoring	Near Continuous Blood Pressure Monitoring
Measure Participants	48	46
Mean (Standard Deviation) [days]	3.7 (4.5)	2.8 (4.8)

3. Secondary Outcome

Title	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.
Description	Total number of organ failure days is for each group as a whole.
Time Frame	Up to two weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description
Measure Participants	46	48
Measure Days	206	202
Number [Days]	18	32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention Group	Control Group
Arm/Group Description
Measure Participants	46	48
Measure Days	206	202
Mean (Standard Deviation) [units on a scale]	22.4 (10.1)	23.9 (10.1)

5. Secondary Outcome

Title	Amount of Intravenous Fluid Resuscitation
Time Frame	At start of inter-facility transport, then every 15 minutes until arrival.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Oscillometric Blood Pressure Monitoring	Near Continuous Blood Pressure Monitoring
Measure Participants	48	46
Mean (Standard Deviation) [ml/kg]	19.8 (22.2)	9.9 (9.9)

Adverse Events

Arm/Group Title	Control Group		Intervention Group
Arm/Group Description	Oscillometric Blood Pressure Monitoring		Near Continuous Blood Pressure Monitoring
All Cause Mortality
	Control Group		Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/46 (0%)

Limitations/Caveats

Small Sample Size. Halted prior to projected enrollment secondary to lack of technical support and supplies for near continuous BP measuring device.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.