Trial Outcomes & Findings for Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test (NCT NCT01848977)

Results Overview

During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Until basline tissue oxygenation value was achieved

Results posted on

2015-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Vascular Occlusion Test The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s. Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vascular Occlusion Test n=20 Participants The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s. Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until basline tissue oxygenation value was achieved

During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.

Outcome measures

Outcome measures
Measure	INVOS® n=20 Participants Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .	InSpectra™ n=20 Participants Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved Desaturation rate	17.9 %/min Standard Deviation 2.3	13.5 %/min Standard Deviation 2.1
Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved Reoxygenation rate	280.0 %/min Standard Deviation 57.5	186.5 %/min Standard Deviation 39.7

PRIMARY outcome

Timeframe: Until basline tissue oxygenation value was achieved

During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.

Outcome measures

Outcome measures
Measure	INVOS® n=20 Participants Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .	InSpectra™ n=20 Participants Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved	23.5 %*min Standard Deviation 9.6	16.4 %*min Standard Deviation 6.3

SECONDARY outcome

Timeframe: Until basline tissue oxygenation value was achieved

Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other.

Outcome measures

Outcome measures
Measure	INVOS® n=20 Participants Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .	InSpectra™ n=20 Participants Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved baseline value before VOT	75.6 percentage of oxyhemoglobin Standard Deviation 8.2	81.8 percentage of oxyhemoglobin Standard Deviation 3.4
Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved minimum value during VOT	39.6 percentage of oxyhemoglobin Standard Deviation 0.5	40.2 percentage of oxyhemoglobin Standard Deviation 0.4
Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved maximum value during VOT	95.1 percentage of oxyhemoglobin Standard Deviation 0.2	94.6 percentage of oxyhemoglobin Standard Deviation 1.7

Adverse Events

Vascular Occlusion Test

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

Jin-Tae Kim

Seoul National University Hospital

Phone: 82-10-6260-8490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place