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This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | ||
| low dose of head down position | Experimental | -10° Trendelenburg for 30 min |
|
| high dose of head down position | Experimental | -10° Trendelenburg for 60 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| head down position | Other | -10° Trendelenburg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. | 24±8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of excellent functional outcome | excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | 90±7 days |
| proportion of favorable functional outcome |
| Measure | Description | Time Frame |
|---|---|---|
| changes in dynamic cerebral autoregulation (dCA) | dCA data include phase difference (the main parameter, determined as the phase shift angle ranging from 0° to 90°), gain (difference in the amplitude between CBFV and ABP), and the coherence function (indicates signal-to-noise ratio), which is determined according to previous report (Guo ZN, Guo WT, Liu J, et al. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning.) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018475 | Head-Down Tilt |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| 90±7 days |
| ordinal distribution of modified Rankin Score (mRS) | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | 90±7 days |
| early neurological improvement (ENI) | ENI is defined as more than 8-point decrease in NIHSS or 0 NIHSS within 24±8 hours | 24±8 hours |
| changes in infarct volume | infarct volume is measured by diffused weighted imaging | 24±8 hours |
| changes in cerebral edema | cerebral edema is determined by brain imaging | 24±8 hours |
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. | 10±2 days |
| new stroke or other vascular event(s) | 90±7 days |
| proportion of sympomatic intracranial hemorrhage | sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage | 24±8 hours |
| proportion of intraparenchymal hemorrhage (PH) | PH was defined as confluent bleeding occupying and causing mass effect | 24±8 hours |
| percentage of severe adverse events | 24±8 hours |
| all-cause mortality | 90±7 days |
| 24±8 hours |
| changes in cortical oxygen saturation | cortical oxygen saturation is determined by near infrared spectroscopy | 24±8 hours |
| changes in serum biomarkers | serum biomarkers include MMP-9, TNF-alpha, IL-1beta, etc. | 24±8 hours |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |