Augmentation of penumbral perfusion through nonpharmacological hemodynamic interventions such as patient positioning may offer a pragmatic approach to improve outcomes in acute ischemic stroke (AIS). This study aimed to assess the feasibility and safety of elevated leg positioning (ELP) in AIS, and to generate preliminary estimates of effect sizes to inform the design of a future definitive randomized trial.
The acute phase of ischemic stroke is a potentially reversible process wherein the extent of tissue injury is dependent on the severity and duration of the perfusion deficit, which are strongly influenced by the adequacy of collateral circulation and the timing of arterial blood flow restoration relative to the window of cellular viability. In addition to pharmacologic and mechanical reperfusion therapies, measures that augment perfusion to the salvageable ischemic penumbra may mitigate subsequent infarct progression and associated neurological deficits. Accordingly, patient positioning strategies intended to enhance cerebral perfusion and oxygenation during the early management of acute ischemic stroke (AIS) may offer a simple and cost-effective nonpharmacologic approach to improve outcomes. Two strategies, the 0° and lower head (-20° Trendelenburg) positions, have been evaluated in randomized clinical trials but have yielded inconclusive findings. This study proposes elevated leg positioning (ELP) while maintaining a 0° head position as a physiologically plausible hemodynamic intervention to optimize penumbral perfusion. In theory, this position would increase venous return and preload, thereby augmenting cardiac output while simultaneously minimizing the hydrostatic pressure gradient between the heart and brain, resulting in increased cerebral perfusion pressure and improved collateral circulation. This may be particularly relevant in the setting of an acute ischemic insult, where focal impairment of cerebrovascular autoregulation may render cerebral blood flow to the penumbra increasingly pressure-passive and dependent on systemic hemodynamics. Furthermore, compared with lower head positioning strategies, maintenance of a neutral head and airway position may confer safety and tolerability advantages. The present study was designed to assess the feasibility and safety of ELP initiated within 24 hours of symptom onset or last known well in patients with moderate anterior circulation ischemic stroke with probable large artery atherosclerosis (LAA) etiology, and to generate preliminary estimates of effect sizes to inform the design and sample size calculation of a future definitive randomized trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Elevated leg positioning (ELP) is a patient positioning strategy initiated no later than 24 hours after stroke onset. Patients are positioned with passive elevation of the legs to 30° while maintaining a 0° head position using calibrated hospital beds. This is maintained for 24 hours, including during eating, drinking, and toileting. After 24 hours, mobilization with toilet privileges may be commenced, and patients are placed in ELP for 3 hours three times daily. Treatment protocol is continued for 7 days. Patients are instructed to report any discomfort while receiving ELP. If deemed uncomfortable or potentially harmful, ELP could be interrupted, during which patients are gradually returned to a horizontal position.
Jose R. Reyes Memorial Medical Center
Manila, NCR, Philippines
Proportion of Participants Adhering to the Assigned Elevated Leg Positioning (ELP) Intervention per Protocol
The primary feasibility outcome was protocol adherence to the assigned elevated leg positioning (ELP) intervention in participants randomized to the intervention arm. Temporary interruption of ELP was permitted for up to three nonconsecutive periods of ≤30 minutes each. Adherence ≥80% prespecified as the threshold for feasibility.
Time frame: From enrollment to the end of treatment at 7 days.
Number of Participants With Prespecified Adverse Events During the Treatment Period
Occurrence of prespecified adverse events during the treatment period. Prespecified adverse events included headache, anxiety or fear, aspiration pneumonia, intracranial hemorrhage, venous thromboembolism (deep vein thrombosis or pulmonary embolism), and other cardiovascular or peripheral vascular events not present at baseline. Serious adverse events were defined according to International Council for Harmonisation Good Clinical Practice criteria and were adjudicated by an independent investigator.
Time frame: From enrollment to the end of treatment at 7 days.
Number of Participants With Early Neurologic Deterioration (END)
Early neurologic deterioration (END), defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours not attributable to intracranial hemorrhage. The NIHSS is a clinician-administered scale used to quantify neurologic deficit in stroke, with scores ranging from 0 to 42, where higher scores indicate more severe neurologic impairment.
Time frame: Within 48 hours after randomization.
Change from Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at Day 7
Change in National Institutes of Health Stroke Scale (NIHSS) score at day 7 compared with baseline. The NIHSS is a clinician-administered scale used to quantify neurologic deficit in stroke, with scores ranging from 0 to 42, where higher scores indicate more severe neurologic impairment.
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Time frame: Baseline and day 7 after randomization.
Number of Participants With All-Cause Mortality at 30 Days
All-cause mortality at 30 days.
Time frame: 30 days after randomization.
Number of Participants With Favorable Functional Outcome at 90 Days
Favorable functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2. The mRS is a measure of functional disability ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death.
Time frame: 90 days after randomization.