Recruitment

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
Age between 18 and 75 years
...
Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
Glasgow Coma Scale ≤ 8 at entrance in ICUs
Age between 18 and 75 years
Adequate respiratory exchange with PaO2/FiO2 ≥ 250
Absence of sedation increased

Exclusion Criteria

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
...
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
Cerebral Perfusion Pressure (PPC) <60 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%
Decompensated liver disease
Intracranial pressure (ICP)> 25 mm / Hg

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
Age between 18 and 75 years
...
Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
Glasgow Coma Scale ≤ 8 at entrance in ICUs
Age between 18 and 75 years
Adequate respiratory exchange with PaO2/FiO2 ≥ 250
Absence of sedation increased

Exclusion Criteria

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
...
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
Cerebral Perfusion Pressure (PPC) <60 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%
Decompensated liver disease
Intracranial pressure (ICP)> 25 mm / Hg

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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