Back to results

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

Primary Purpose

Brain Injury

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Early rehabilitation treatment on Erigo Hocoma

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring brain injury, coma, intensive care, early rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erigo treated

Arm Description

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

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

Changes of hemodynamic parameters

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.

Full Information

NCT ID

NCT02100592

First Posted

March 24, 2014

Last Updated

March 27, 2014

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

1. Study Identification

Unique Protocol Identification Number

NCT02100592

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury

Keywords

brain injury, coma, intensive care, early rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erigo treated

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Early rehabilitation treatment on Erigo Hocoma

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Early rehabilitation treatment on Erigo Hocoma

Intervention Description

Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system

Primary Outcome Measure Information:

Title

Adverse events during verticalization

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes of hemodynamic parameters

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Frazzitta, MD

Organizational Affiliation

Ospedale generale di zona 'Moriggia Pelascini'

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Roberto Valsecchi, MD

Organizational Affiliation

Ospedale generale di zona 'Moriggia Pelascini'

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leopold Saltuari, MD

Organizational Affiliation

LDK Hochzirl

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luca Sebastianelli, MD

Organizational Affiliation

Ospedale generale di zona 'Moriggia Pelascini'

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs