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

NCT02100592 | Completed Phase 1

• 1 other identifier: ERIGO-1
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Injury

Keywords

brain injury; coma; intensive care; early rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adverse events during verticalization

  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;

  21 days: from T1 (first session) to T15 (last session)

Secondary Outcomes (1)

• Changes of hemodynamic parameters

  21 days: from T1 (first session) to T15 (last session)

Study Arms (1)

Erigo treated

EXPERIMENTAL

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

Other: Early rehabilitation treatment on Erigo Hocoma

Interventions

Early rehabilitation treatment on Erigo Hocoma OTHER

5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °

Erigo treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

MeSH Terms

Conditions

Brain Injuries; Coma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Frazzitta, MD

  Ospedale generale di zona 'Moriggia Pelascini'

  STUDY CHAIR

• 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'

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 1, 2014
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 1, 2014

Record last verified: 2014-03