Trial Outcomes & Findings for Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport (NCT NCT00279591)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

Up to two weeks

Results posted on

2012-04-30

Participant Flow

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

Participant milestones

Participant milestones
Measure	Control Group Oscillometric Blood Pressure Monitoring	Intervention Group Near Continuous Blood Pressure Monitoring
Overall Study STARTED	48	46
Overall Study COMPLETED	48	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=48 Participants Oscillometric Blood Pressure Monitoring	Intervention Group n=46 Participants Near Continuous Blood Pressure Monitoring	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	8.5 years STANDARD_DEVIATION 5.6 • n=5 Participants	6.5 years STANDARD_DEVIATION 4.6 • n=7 Participants	7.5 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	46 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to two weeks

Population: Intention to Treat

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.

Outcome measures

Outcome measures
Measure	Control Group n=48 Participants Oscillometric Blood Pressure Monitoring	Intervention Group n=46 Participants Near Continuous Blood Pressure Monitoring
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	5.4 days Standard Deviation 4.6

SECONDARY outcome

Timeframe: Up to two weeks

Outcome measures

Outcome measures
Measure	Control Group n=48 Participants Oscillometric Blood Pressure Monitoring	Intervention Group n=46 Participants Near Continuous Blood Pressure Monitoring
Intensive Care Unit (ICU) Length of Stay	3.7 days Standard Deviation 4.5	2.8 days Standard Deviation 4.8

SECONDARY outcome

Timeframe: Up to two weeks

Population: ITT

Total number of organ failure days is for each group as a whole.

Outcome measures

Outcome measures
Measure	Control Group n=206 Days Oscillometric Blood Pressure Monitoring	Intervention Group n=202 Days Near Continuous Blood Pressure Monitoring
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	32 Days

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Control Group n=206 Days Oscillometric Blood Pressure Monitoring	Intervention Group n=202 Days Near Continuous Blood Pressure Monitoring
Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.	22.4 units on a scale Standard Deviation 10.1	23.9 units on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: At start of inter-facility transport, then every 15 minutes until arrival.

Outcome measures

Outcome measures
Measure	Control Group n=48 Participants Oscillometric Blood Pressure Monitoring	Intervention Group n=46 Participants Near Continuous Blood Pressure Monitoring
Amount of Intravenous Fluid Resuscitation	19.8 ml/kg Standard Deviation 22.2	9.9 ml/kg Standard Deviation 9.9

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Stroud

University of Arkansas for Medical Sciences

Phone: 501-364-1861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place