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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
| University of Sao Paulo | OTHER |
| Technology Agency of the Czech Republic | UNKNOWN |
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Prevention of lung inhomogeneity is an essential part of preventive strategy in neurocritical care, reducing the risks of secondary brain damage from hypoxemia, hypo/hypercapnia or pneumonia.
In the monocentric, intervention, prospective, randomized study, the investigators will examine the effect of lateral tilting (routinely used in critical care) on the lung inhomogeneity that will be analyzed by electrical impedance tomography (EIT) in the unconscious patients with acute primary brain disease and artificial pulmonary ventilation. Two types of lateral tilting will be compared: manual positioning of body by nurse versus the bed tilting (15° lateral tilt, original company (LINET) and product brand name (Eleganza 5).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral tilt bed | Experimental | Bed tilting (15° lateral tilt, original product brand name LINET Eleganza 5) |
|
| Body positioning | Experimental | Manual positioning of body by nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bed tilting | Device | 15° lateral tilt, original product brand name LINET Eleganza 5 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Atelectasis/collapse | Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating oxygenation parameters | Oxygen saturation | up to 24 weeks |
| Evaluating hemodynamic parameters | Hemodynamic monitoring: stroke volume variation (SVV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vera Spatenkova, MD, Ph.D. | NeuroCenter | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Liberec | Liberec | 46010 | Czechia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2020 | Jan 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D011187 | Posture |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Research Randomizer
| Body positioning |
| Other |
Manual positioning of body by nurse: left side, back, right side, using positioning pillows |
|
|
| up to 24 weeks |
| Cost effectiveness measurement between two groups | Therapeutic Intervention Scoring System (TISS) | up to 24 weeks |
| Profiling pneumonia incidence | Pneumonia score | up to 24 weeks |
| Comparing duration of stay in Neurocenter Neurointensive Care Unit | Days of hospitalization | up to 24 weeks |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |