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

Who is this study for? Patients with Acute Ischemic Stroke
What treatments are being studied? Allocating Head-of-Bed Position
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Positioning of the patient with hyperacute large artery ischemic stroke (IS) is an important, yet understudied aspect of care that could impact the course of treatment and ultimately clinical outcome. Positioning with the head of bed (HOB) at 0-degree has been shown in small studies to increase cerebral blood flow across arterial occlusion in hyperacute large artery IS, leading to clinical improvement in stroke symptoms. However, this position is believed to increase the risk of aspiration pneumonia. In this randomised clinical trial, the investigators aim to evaluate whether use of 0-degree HOB positioning is associated with clinical stability in hyperacute IS. Investigators hypothesise that patients with large artery occlusions placed in a 0-degree HOB position will experience less early neurologic deterioration within the first 24 hours, than those in the 30-degree or more HOB elevation group. The study aims to confirm the safety of 0-degree-HOB positioning in a large, generalizable sample of hyperacute large artery IS patients. In this randomised trial, patients presenting to the study centers and eligible for intravenous thrombolysis, with (if presenting within 4.5 hours of symptom-onset) or without (presenting between 4.5 to 16 hours of symptom-onset) mechanical thrombectomy. Eligible patients would be randomised to either a zero-degree HOB or an HOB of 30-degree or more. Impact of HOB position on neurological status would be evaluated with serial NIHSS scores. Cerebral hemodynamics would be monitored by transcranial Doppler ultrasonography. Validated criteria would be used to diagnose pneumonia. Functional outcome would be measured by modified Rankin scale (mRS) where the score of 0-2 describe good functional recovery. SPSS version 20 would be used to analyse the data. The trial would provide clinical and hemodynamic data to determine the optimal HOB position in patients with large artery acute ischemic stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
Singapore
Division of Neurology, National University Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
VIJAY K SHARMA, MD
mdcvks@nus.edu.sg
91389555
Backup
Lily YS Wong, RN
lily_wong@nuhs.edu.sg
67795555
Time Frame
Start Date: 2020-02-11
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 182
Treatments
Active_comparator: 0 degree Head-of-Bed (HOB) position
Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position
Active_comparator: Elevated (30-degree or more) head-of-bed
Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position
Related Therapeutic Areas
Sponsors
Leads: National University of Singapore

This content was sourced from clinicaltrials.gov

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