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OpenTrials
Completed

NCT Number: NCT02100592

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early rehabilitation treatment on Erigo Hocoma

Other

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

Primary outcomes

  1. 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

  1. Changes of hemodynamic parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2014
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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