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

November 13, 2023 updated by: VIJAY KUMAR SHARMA, National University of Singapore
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Positioning of the patient with hyperacute 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. On the other hand, small studies have also documented clinical symptom worsening in IS patients when the HOB was elevated to 30-degree or higher.

A recent large cluster randomized trial (HeadPoST) attempted to determine the optimal head position in acute IS, but failed to enrol the patient cohort for which 0-degree head positioning may be beneficial. Findings from HeadPoST have been debated by the stroke neurologists due to some design flaws and enrolment of inappropriate patients to answer this question. In fact, HeadPoST has become a catalyst for conducting a high quality head positioning research in hyperacute large artery IS to definitively answer the question of how best to manage these highly vulnerable patients to ensure stability and prevent symptom worsening.

Mechanisms proposed for clinical improvement at 0-degree-HOB include favorable gravitational arterial flow conditions, recruitment of collateral vessels, and in the case of intravenous thrombolysis, improved clot-lytic interactions augmenting arterial recanalization. Collectively, these mechanisms may support the argument that 0-degree-HOB positioning should be among the first steps taken in large artery hyperacute IS patient management.

This efficacy study aims to determine if 0 degree-HOB positioning in hyperacute IS prevents neurological symptom worsening in large artery occlusion patients. The study will achieve these goals through use of a novel protocol enabling enrolment of consecutive large artery occlusion patients while maintaining compliance with management specified by the guidelines.

This phase III study will utilize a prospective randomized outcome-blinded evaluation (PROBE) approach enrolling consecutive hyperacute large artery IS patients to determine if use of 0-degreeHOB positioning is associated with greater clinical stability.

Suspected acute IS patients admitted to the study center(s) will undergo guideline-supported standard of care stroke team emergency response procedures, including assessment/ stabilization of airway, breathing, circulation with immediate transport for imaging. Continuous portable ECG monitoring and nasal canula oxygen will be established in CT (or MRI), and IV access will be obtained with STAT blood draw; point of care testing will be conducted immediately before STAT non-contrast CT (or MRI) with CTA (or MRA). The NIHSS will then be scored by the stroke team, followed by standard of care placement of a continuous pulse oximetry sensor, and completion of a rapid/detailed history/physical exam. Patients eligible for treatment with IV-tPA will have drug administered, and standard of care admission upright chest x-ray (CXR) will then be performed. Subjects meeting inclusions without exclusions will then be consented, randomized, and placed in the assigned HOB position, signaling the beginning of the monitoring phase of the intervention.

Patients will be transferred to the catheterization lab for mechanical thrombectomy (MT) once the team is ready for the procedure. Thrombectomy requires transfer from the ED to catheterization lab, with 0-degree-HOB positioning commencing immediately prior to groin puncture constituting the end of the head positioning phase of the protocol. Thrombectomy patients are extremely likely to benefit from 0-degree-HOB positioning because the procedure is only performed in patients without evidence of completed infarction. This novel protocol will capture serial NIHSS over the period before thrombectomy begins, allowing us to better understand how to maintain stability in this high risk vulnerable population.

Enrolled patients will be randomized to either 0-degree-HOB or 30-degree (or more) HOB positioning, and will undergo serial NIHSS assessments every 15mins +/- 5 mins while awaiting start of the thrombectomy. The patients will also undergo 24-hour ± 6hrs, 72hrs ± 12hrs discharge/7day, and 90-day +/- 14 days outcome monitoring, but these will be collected for exploratory purposes only. The NIHSS and mRS will be performed by credentialed members of the team. In addition to the chest X-Ray, blood will be drawn after obtaining the consent for HSCRP and Procalcitonin levels, primarily to substantiate the diagnosis of pre-hospital arrival chest infection, if any.

To assure balance in the treatment group throughout the course of enrolment, the investigators will use block randomization with a block size of 4 and an allocation ratio of 1:1. This scheme only shows the random assignment for a single given participant. Future assignments cannot be predicted by study personnel, and this effectively mitigates the risk for selection bias.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 119228
        • Recruiting
        • National University Hospital
        • Contact:
      • Singapore, Singapore, 119074
        • Recruiting
        • Division of Neurology, National University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Biological: Allocating head-of-bed 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
Biological: Allocating head-of-bed position
Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
National Institute of Health Stroke Scale (NIHSS) change (higher change means more improvement) at day-7 and modified Rankin Score (mRS) at day-7
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMRC/CIRG/18nov-0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD would be shared after completion of the study upon reasonable request

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

Upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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