Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study

Phase 1

Completed

• Conditions: Brain Injury
• Interventions: Other: Early rehabilitation treatment on Erigo Hocoma

• Registration Number: NCT02100592
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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).

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-02
• Status Verified: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Study First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

1. Major chest trauma with multiple rib fractures and / or pneumothorax
2. Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
3. Cardiovascular instability despite support with amines
4. Intracranial pressure (ICP)> 25 mm / Hg
5. Cerebral Perfusion Pressure (PPC) <60 mm / Hg
6. Severe kidney failure requiring replacement therapy
7. Decompensated liver disease
8. Hematocrit value of ≤ 30%
9. Body weight> 135 kg or height> 210 cm
10. Deep vein thrombosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erigo treated	Early rehabilitation treatment on Erigo Hocoma	Early rehabilitation treatment on Erigo Hocoma, a tilt table with integrated stepping device within 3 - 30 days from injury

Primary Outcome Measures

Name	Time	Method
Adverse events during verticalization	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 Outcome Measures

Name	Time	Method
Changes of hemodynamic parameters	21 days: from T1 (first session) to T15 (last session)	Changes of hemodynamic parameters during each session and from T1 to T15; assessed parameters are: stroke volume; peripheral resistances; mean arterial pressure; cerebral perfusion pressure.