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

NCT05073159 | Unknown Phase 3 DMC

• 1 other identifier: NMRC/CIRG/18nov-0012
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• National Institute of Health Stroke Scale (NIHSS) change (higher change means more improvement) at day-7 and modified Rankin Score (mRS) at day-7

  Investigators will analyze the data by dichotomized modified Rankin Score (mRS) 0-2 (good functional outcome) versus 3-6 (poor outcome) as well as mrs 0-1 (excellent outcome) versus mRS 2-6 (unfavorable outcome) as well as ordinal shift across the range of mRS 0-6

  day-7

• National Institute of Health Stroke Scale (NIHSS) change (higher value indicate more improvement) at day-90 and modified Rankin Score (mRS) at day-90

  Investigators will analyze the data by dichotomized mRS (0-2 as good functional outcome versus 3-6 as poor outcome), mRS (0-1 as excellent functional outcome versus 2-6 as unfavorable outcome) as well as ordinal shift across entire range of mRS 0-6.

  day-90

Study Arms (2)

0 degree Head-of-Bed (HOB) position

ACTIVE COMPARATOR

Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position

Biological: Allocating head-of-bed position

Elevated (30-degree or more) head-of-bed

ACTIVE COMPARATOR

Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position

Biological: Allocating head-of-bed position

Interventions

Allocating head-of-bed position BIOLOGICAL

Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position

0 degree Head-of-Bed (HOB) position; Elevated (30-degree or more) head-of-bed

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (2)

Division of Neurology, National University Hospital

Singapore, 119074, Singapore

RECRUITING

National University Hospital

Singapore, 119228, Singapore

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

VIJAY K SHARMA, MD

CONTACT

91389555; mdcvks@nus.edu.sg

Lily YS Wong, RN

CONTACT

67795555; lily_wong@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled study

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 11, 2021
• Study Start: February 11, 2020
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study completion
• Access Criteria: Upon reasonable request

Locations

SG (2)