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In accordance with the interim statistical analysis conducted after 250 patients.
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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
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Patient positioning is an essential part of a preventive strategy for neurocritical care patients.
The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.
In the monocentric, intervention, prospective, randomized study, we will investigate incidence of pressure ulcer in 300 adult consecutive patients admitted to our Neurointensive Care Unit (NICU). All patients will suffer from acute primary brain disease and will be unconscious with artificial pulmonary ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral tilt bed | Experimental | Special lateral tilt bed. |
|
| Body positioning | No Intervention | Standard NICU preventive strategy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body positioning | Other | Comparison lateral tilt bed to standard patient´s body positioning in the bed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pressure ulcer | Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel) | Through study completion, on average every 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonging the stay in the NICU | The incidence of the pressure ulcer shall prolong the patient´s NICU stay | Through study completion, on average every 24 weeks. |
| Cost effectiveness of patient´s NICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vendula Machackova, MSc., Ph.D. | Department for Science and Reseach | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Liberec | Liberec | 46010 | Czechia |
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
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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 | Aug 27, 2019 | Aug 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003244 | Consciousness Disorders |
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| ID | Term |
|---|---|
| D011187 | Posture |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.
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Research Randomizer
Therapeutic Intervention Scoring System (TISS)
| Through study completion, on average every 24 weeks. |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |