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

Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100592
• Other study ID #: ERIGO-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 24, 2014
• Last updated: March 27, 2014
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministero della Salute, dell Università e della Ricerca
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Intervention

Other:
• Early rehabilitation treatment on Erigo Hocoma
5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °
• Early rehabilitation treatment on Erigo Hocoma
Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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.	21 days: from T1 (first session) to T15 (last session)	No