Head of Bed Positioning for Stroke

(HoBIT Trial)

SB
AT
Overseen ByAmanda Taylor, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Population Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the position of the bed's head aids stroke patients' recovery after endovascular thrombectomy (EVT), a procedure that removes blood clots from the brain. Researchers aim to determine if lying flat (0-degrees) or with the head raised (30-degrees or more) enhances recovery. This study targets adults who have experienced a stroke and are undergoing EVT to remove clots from large brain vessels. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance stroke recovery methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this head of bed positioning is safe for stroke patients?

Research has shown that keeping stroke patients lying flat (0-degree head position) is generally safe. In a study with 92 patients, this position helped prevent their condition from worsening. Additionally, in another group, only 6.3% of patients lying flat experienced major neurological problems, compared to 17.2% of those with their heads raised. These findings suggest that lying flat may lead to better outcomes by improving blood flow to the brain without causing harm.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the positioning of the head of bed can impact recovery from a stroke. Most current treatments for stroke focus on medications to dissolve clots or surgical interventions to restore blood flow. This trial is investigating whether simply adjusting the angle of the bed can make a difference. The potential benefit is that it’s a non-invasive, low-cost method that could be easily implemented in hospitals everywhere, making it an accessible option for improving patient outcomes.

What evidence suggests that head of bed positioning is effective for improving recovery after a stroke?

Research has shown that keeping the head of the bed flat can benefit stroke patients undergoing procedures to remove blood clots from the brain. In a study with 92 patients, this flat position proved safe and helped prevent their condition from worsening. Other research suggests that lying flat can lead to better stability and improvement. This trial will compare two head-of-bed positions: one group will lie flat (0-degrees), a position linked to increased blood flow to the brain in patients with strokes caused by blocked arteries. The other group will have a head-of-bed position of 30-degrees or greater. These studies suggest that lying flat might aid recovery after stroke treatment.12456

Who Is on the Research Team?

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Mike Sharma, MD

Principal Investigator

Population Health Research Institute

AK

Aristeidis Katsanos, MD

Principal Investigator

Population Health Research Institute

Are You a Good Fit for This Trial?

The HoBIT trial is for adults who've had a stroke and are undergoing a procedure called EVT to remove blood clots from the brain. Participants must be able to consent, be 18 or older, and have specific types of blockages in their brain's arteries.

Inclusion Criteria

I am 18 years old or older.
I am eligible for a clot removal procedure in my brain's large arteries.
I can sign the consent form myself or have someone legally allowed to do it for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endovascular thrombectomy (EVT) and are assigned to head of bed positioning at 0-degrees or 30-degrees or more

Immediate post-procedure
In-hospital stay

Initial Follow-up

Participants are monitored for early neurological improvement and functional impairment

7 days or until discharge
Daily monitoring

Extended Follow-up

Participants are assessed for functional disability and quality of life

90±14 days
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Head of bed position of 0-degrees
  • Head of bed position of 30-degrees or greater

Trial Overview

Researchers are testing whether lying flat (0-degrees) or at an angle (30-degrees or more) after clot removal affects recovery from stroke. The goal is to see which head position leads to better functional outcomes post-procedure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Intervention ArmExperimental Treatment1 Intervention
Group II: Control ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials
165
Recruited
717,000+

Citations

Optimal Head-of-Bed Positioning Before Thrombectomy in ...

In this randomized clinical trial including 92 patients, use of a 0° head position was safe and prevented clinical worsening, whereas a 30° head ...

ZODIAC trial demonstrates the impact of head-of-bed ...

The interim analysis found that positioning patients at 0-degrees HOB resulted in greater clinical stability and/or clinical improvement ...

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

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 ...

Zero Degree Head Positioning in Hyperacute Large Artery ...

Placing the head of bed (HOB) at 0-degrees has been shown in small studies to improve blood flow to the brain in patients with ischemic stroke caused by ...

Position of stroke patient's head before surgery may ...

An interim analysis found that 0-degree head positioning before thrombectomy surgery resulted in greater stability and/or clinical improvement ...

Head-of-bed positioning in large artery acute ischemic stroke

Compared to only 4/64 (6.3 %) patients in 0-degree HOB, 10/58 (17.2 %) patients with elevated HOB developed significant neurological deterioration (p = 0.001).