Trial Outcomes & Findings for In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome (NCT NCT01452425)

Results Overview

A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block. Measures were: \[mean (SD)\] INVOS (in %) value at baseline and at the time of the block

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

45 minutes

Results posted on

2014-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Tourniquet Inflation of a tourniquet Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tourniquet n=10 Participants No adverse event
Age, Customized age	33 years STANDARD_DEVIATION 4 • n=113 Participants
Sex: Female, Male Female	0 Participants n=113 Participants
Sex: Female, Male Male	10 Participants n=113 Participants

PRIMARY outcome

Timeframe: 45 minutes

A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block. Measures were: \[mean (SD)\] INVOS (in %) value at baseline and at the time of the block

Outcome measures

Outcome measures
Measure	Tourniquet n=10 Participants Inflation of a tourniquet Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Comparison Between INVOS Monitoring and Electromyography INVOS (Baseline)	73 % of StcO2 Standard Deviation 9
Comparison Between INVOS Monitoring and Electromyography INVOS (At time of the block)	46 % of StcO2 Standard Deviation 11

PRIMARY outcome

Timeframe: 45 minutes

\[mean (SD)\] ICP (in mmHg), value at baseline and at the time of the block

Outcome measures

Outcome measures
Measure	Tourniquet n=10 Participants Inflation of a tourniquet Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Intracompartmental Pressure (ICP) ICP (Baseline)	17 mmHg Standard Deviation 9
Intracompartmental Pressure (ICP) ICP (At time of the block)	70 mmHg Standard Deviation 6

Adverse Events

Tourniquet

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

Pr Patrice Forget

UCLouvain

Phone: 3227641821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place