Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Screening tool Coma Near Coma (CNC) scale |
The CNC is a scale for patients with acquired brain injury, who function at very low levels of consciousness. The scale evaluates the occurrence of responses to visual, auditory, command following, threat response, olfactory, tactile, pain and vocalization. The CNC is both a quantitative assessment-with scores ranging from 4 (lowest level of consciousness) to 0 (highest level of consciousness)-and a qualitative assessment-with 5 levels comprising extreme coma (3.5-4), marked coma (2.9-3.49), moderate coma (2.01-2.89), near coma (0.9-2), no coma (0-0.89). Patients will be considered for the research between level 4-extreme coma to level 1-near coma. |
This tool will be used once as a filter to participate in research one day prior to measuring the baseline |
|
| Primary |
Behavioral pain scale (BPS) change |
BPS evaluates three behavioral domains (facial expressions, movement of upper limbs, and compliance with ventilation) that are based on observation of the patient body's posture and his response to a nociceptive stimulation. Each subscale is scored from 1 (no response) to 4 (full response). Therefore, possible BPS scores range from 3 (no pain) to 12 (maximum pain). |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14 |
|
| Primary |
Modify Ashworth scale (MAS) change |
MAS is used to measure the increase of muscle tone which is manifested by an increased resistance of joints to passive movement. The MAS measures on the following 6 level ordinal scale: 0 = no increased resistance; 1 = slightly increased resistance (catch followed by relaxation or minimal resistance at the end of the range of motion); 1+ = slightly increased resistance (catch followed by minimal resistance throughout less than half of the range of motion); 2 = clear resistance throughout most of the range of motion; 3 = strong resistance; passive movement is difficult; 4 = rigid flexion or extension. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14 |
|
| Primary |
EEG brainwave change |
EEG will be sampled using the Mind-Wave dry electrode system, with one frontal electrode and one reference electrode on the earlobe, at a sampling rate of 512Hz. Positioning of the electrode conforms with the goal of monitoring prefrontal activity, which may correlate with attention regardless of the site of lesion. The sampled data is transferred through a wireless connection to the computer, where the Brain Engagement Index (BEI) is processed in real-time every 10 seconds and presented by the BEI monitor. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14 |
|
| Primary |
Respiratory Rate (RR) change |
The set ventilatory rate is the minimum number of breaths delivered to the patient per minute. The actual rate may be higher than the set rate if the patient is initiating spontaneous breaths. Rate is also a determinant of ventilation and is adjusted in response to the patient's CO2 (carbon dioxide) levels. RR will be collected from the patient's respiratory machine. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days |
|
| Primary |
Tidal Volume (TV) change |
Tidal volume (TV) is the volume of gas delivered to the patient with each breath. Tidal volume may also be expressed as TV. TV is only set for volume-controlled modes of ventilation and is usually 8-12cc/kg of body weight. TV will be collected from the patient's respiratory machine. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days |
|
| Primary |
Peak Inspiratory Pressure (PIP) change |
Inspiratory pressure reflects global alveolar pressure and is monitored continuously. The maximum allowable PIP is set on the ventilator. If the PIP exceeds the set value, an alarm will sound, and gas delivery will halt until the next breath is triggered. The normal peak inspiratory pressure on a mechanically ventilated patient with normal lungs is approximately 20cm H2O (water). The maximum allowable peak pressure varies from patient to patient. The pulmonologists determine the safest pressure for each patient. PIP values should be trended in volume-controlled modes to detect changes in pulmonary compliance. PIP will be collected from the patient's respiratory machine. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days |
|
| Primary |
Systolic Blood Pressure (SBP) change |
SBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Cross-sectional values for systolic blood pressure: norm 120-129, normal-high 130-139, and hypertension =140. SBP will be collected using a monitoring equipment located in the departments. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days |
|
| Primary |
Diastolic Blood Pressure (DBP) change |
DBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Optimal diastolic blood pressure values <80, with cross-sectional points to norm 80-84, normal-high 85-89, and hypertension =90. DBP will be collected using a monitoring equipment located in the departments. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days |
|
| Primary |
Heart Rate (HR) change |
HR will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. The average pulse value is 60-80 beats per minute. HR will be collected using a monitoring equipment located in the departments. |
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days |
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