Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- Glasgow Coma Scale ≤ 8 at entrance in ICUs
- Absence of sedation increased
- ...
- Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- Glasgow Coma Scale ≤ 8 at entrance in ICUs
- Absence of sedation increased
- Adequate respiratory exchange with PaO2/FiO2 ≥ 250
- Age between 18 and 75 years
Exclusion Criteria
- Decompensated liver disease
- Cerebral Perfusion Pressure (PPC) <60 mm / Hg
- Intracranial pressure (ICP)> 25 mm / Hg
- ...
- Decompensated liver disease
- Cerebral Perfusion Pressure (PPC) <60 mm / Hg
- Intracranial pressure (ICP)> 25 mm / Hg
- Deep vein thrombosis
- Major chest trauma with multiple rib fractures and / or pneumothorax
- Severe kidney failure requiring replacement therapy
- Hematocrit value of ≤ 30%
- Body weight> 135 kg or height> 210 cm
- Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
- Cardiovascular instability despite support with amines
Summary
- Conditions
- Brain Injury
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).
Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).
Inclusion Criteria
- Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- Glasgow Coma Scale ≤ 8 at entrance in ICUs
- Absence of sedation increased
- ...
- Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- Glasgow Coma Scale ≤ 8 at entrance in ICUs
- Absence of sedation increased
- Adequate respiratory exchange with PaO2/FiO2 ≥ 250
- Age between 18 and 75 years
Exclusion Criteria
- Decompensated liver disease
- Cerebral Perfusion Pressure (PPC) <60 mm / Hg
- Intracranial pressure (ICP)> 25 mm / Hg
- ...
- Decompensated liver disease
- Cerebral Perfusion Pressure (PPC) <60 mm / Hg
- Intracranial pressure (ICP)> 25 mm / Hg
- Deep vein thrombosis
- Major chest trauma with multiple rib fractures and / or pneumothorax
- Severe kidney failure requiring replacement therapy
- Hematocrit value of ≤ 30%
- Body weight> 135 kg or height> 210 cm
- Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
- Cardiovascular instability despite support with amines
Tracking Information
- NCT #
- NCT02100592
- Collaborators
- Not Provided
- Investigators
- Study Chair: Giuseppe Frazzitta, MD Ospedale generale di zona 'Moriggia Pelascini' Principal Investigator: Roberto Valsecchi, MD Ospedale generale di zona 'Moriggia Pelascini' Principal Investigator: Leopold Saltuari, MD LDK Hochzirl Principal Investigator: Luca Sebastianelli, MD Ospedale generale di zona 'Moriggia Pelascini'
- Study Chair: Giuseppe Frazzitta, MD Ospedale generale di zona 'Moriggia Pelascini' Roberto Valsecchi, MD Ospedale generale di zona 'Moriggia Pelascini' Principal Investigator: Leopold Saltuari, MD LDK Hochzirl Principal Investigator: Luca Sebastianelli, MD Ospedale generale di zona 'Moriggia Pelascini'
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