Evaluating head positioning for patients with acute ischemic stroke

Head-of-Bed Positioning in Large Artery Acute Ischemic Stroke

This study tests if keeping the head of the bed flat at 0 degrees helps people with a severe stroke feel more stable and prevents their condition from getting worse compared to keeping it elevated at 30 degrees.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: National University of Singapore (other)
• Locations: 2 sites (Singapore and 1 other locations)
• Trial ID: NCT05073159 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of head-of-bed (HOB) positioning at 0 degrees on patients with hyperacute large artery ischemic stroke. The study aims to determine if this positioning can lead to improved clinical stability and reduced early neurologic deterioration compared to a 30-degree elevation. By randomizing patients and monitoring their outcomes, the trial seeks to provide definitive evidence on the safety and efficacy of this intervention. The research builds on previous findings and aims to address gaps in knowledge regarding optimal patient positioning in acute stroke care.

Who should consider this trial

Good fit: Ideal candidates include individuals experiencing ischemic stroke symptoms consistent with large artery occlusion who can be enrolled and treated promptly.

Not a fit: Patients with evolving malignant infarction or those requiring intubation or mechanical ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved clinical outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While previous studies have explored head positioning in stroke care, this trial aims to address limitations in those studies and provide new insights.

Eligibility criteria

Inclusion Criteria:

* • Ischemic stroke symptoms consistent with large artery occlusion

  * Baseline non-contrast head CT (or MRI) negative for hemorrhage or mass- effect
  * Evidence of arterial occlusion on standard of care CT angiography or MR angiography or NIHSS 10 or more points
  * Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] \>6
  * Patients treated with IV-tPA, mechanical thrombectomy or both
  * Pre-stroke baseline modified Rankin Score (mRS) \<1
  * Ability to enrol, randomize and begin the intervention within the Emergency Department

Exclusion Criteria:

* • Pregnancy or suspicion of pregnancy

  * Evidence or suspicion of vomiting any time prior to consent which could predispose to aspiration pneumonia and therefore confound determination of protocol safety
  * Evidence of evolving malignant infarction on admission noncontrast CT (or MRI)
  * Need for intubation with mechanical ventilation, or non-invasive ventilatory support with either bi-level positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP)
  * Inability to tolerate zero-degree positioning due to congestive heart failure, preexisting pneumonia, chronic obstructive pulmonary disease, or other medical condition
  * Admission chest radiograph positive for pleural effusion, pulmonary edema, pneumonia, or other pulmonary condition that may confound determination of protocol safety
  * Abnormal breath sounds on that may confound determination of protocol safety

Where this trial is running

Singapore and 1 other locations

• Division of Neurology, National University Hospital — Singapore, Singapore (RECRUITING)
• National University Hospital — Singapore, Singapore (RECRUITING)

Study contacts

• Study coordinator: VIJAY K SHARMA, MD

Conditions: Acute Ischemic Stroke