Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Brain Injury
- Sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Enrollment
- 8
- Primary Endpoint
- Adverse events during verticalization
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- •Age between 18 and 75 years
- •Glasgow Coma Scale ≤ 8 at entrance in ICUs
- •Adequate respiratory exchange with PaO2/FiO2 ≥ 250
- •Absence of sedation increased
Exclusion Criteria
- •Major chest trauma with multiple rib fractures and / or pneumothorax
- •Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
- •Cardiovascular instability despite support with amines
- •Intracranial pressure (ICP)\> 25 mm / Hg
- •Cerebral Perfusion Pressure (PPC) \<60 mm / Hg
- •Severe kidney failure requiring replacement therapy
- •Decompensated liver disease
- •Hematocrit value of ≤ 30%
- •Body weight\> 135 kg or height\> 210 cm
- •Deep vein thrombosis
Outcomes
Primary Outcomes
Adverse events during verticalization
Time Frame: 21 days: from T1 (first session) to T15 (last session)
It is a composite outcome, assessing the occurence of at least one of the following conditions (component outcomes): Heart rate \<40 bpm or\> 150 bpm; Mean arterial pressure \<70 mmHg; Arterial oxygen saturation \<90%; Onset of ECG anomalies; Traumatic dislodgement of a device;
Secondary Outcomes
- Changes of hemodynamic parameters(21 days: from T1 (first session) to T15 (last session))