The Investigation of the Impact of Early Mobilization on the Outcome, the Appearance of Early Ischemic Damage, the Functional Status, and the Length of Intensive Care Treatment in Patients With Aneurysmal Subarachnoid Hemorrhage.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early Ambulation
- Sponsor
- University of Pecs
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.
Researchers will compare early mobiliziation vs. standrad bed rest care.
Investigators
Péter Csécsei
Assistant Professor
University of Pecs
Eligibility Criteria
Inclusion Criteria
- •Age \>18 ys
- •Premorbid modified Rankin Scale score of 0-2
- •WFNS I-IV at enrollment
- •Aneurysm occlusion has occurred through open or endovascular means
- •Minimum 24 hours elapsed after aneurysm occlusion
- •The patient has not received thrombolytic therapy
- •Vital parameters are appropriate (mean arterial pressure \[MAP\] \>80 or \>110 mm Hg)
- •Signed patient information and consent form
- •Enrollment occurs within 72 hours following ictus
Exclusion Criteria
- •Age under 18 years
- •Traumatic subarachnoid hemorrhage
- •Incapacitated or limited capacity for action before ictus
- •Confirmed pregnancy
- •Aneurysm multiplicity (unless all aneurysms are treated)
Outcomes
Primary Outcomes
Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
Time Frame: 14 day; 3 months
Extended Glasgow Outcome Scale Description of the neurological outcome by using extended Glasgow Outcome Score 1. Death 2. Vegetative sate 3. Lower severe disability 4. Upper severe disability 5. Lower moderate disability 6. Upper moderate disability 7. Lower good recovery 8. Upper good recovery Assessment is performed by a blinded investigator of the local study center by personal visit.
Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
Time Frame: 14 day; 3 months
Outcome assessments will include: Modified Rankin Scale Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit.
Secondary Outcomes
- Readmission to the ICU(Up to 30 days)
- Onset of delayed cerebral ischemia (DCI)(3-21 days)
- Type of post-hospital discharge placement(Up to 30 days)
- Onset of severity of macrovascular vasospasm(Up to 14 days)
- Stay in the Intensive Care Unit (ICU)(Up to 28 days)
- Barthel score(14 day; 3 months)
- Occurrence of infection and its time in the intensive care unit(Up to 30 days)
- Montreal Cognitive Assessment (MoCA)(14 day; 3 months)
- Functional Independence Measure (FIM) scale(14 day)
- Hospital Anxiety and Depression Scale (HADS)(14 day; 3 months)