Recruiting

Head Positioning

Sponsor:

Population Health Research Institute

Code:

NCT07367633

Conditions

Large Vessel Occlusion

Stroke

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Head of bed position of 0-degrees

Head of bed position of 30-degrees or greater

Study Details

Brief summary:

Endovascular thrombectomy (EVT), also known as clot retrieval, is a procedure that improves recovery for people who suffer a stroke by removing blood clots from large blood vessels in the brain. However, half of the patients undergoing EVT to remove the clot from a brain vessel still face lasting disabilities or even die within three months.

The investigators of the HoBIT trial are trying to find out if the position of the head of bed improves recovery in patients who undergo EVT after suffering from a stroke.

The purpose of this study is to establish the benefit of head of bed positioning at 0-degrees compared with 30-degrees or more after EVT for improving functional outcomes in adults that suffer from a stroke.

Conditions

Large Vessel Occlusion

Stroke

Ischemic Stroke

Study ID

NCT07367633

Start date

Sep 3, 2026

Status verified date

Sep, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older on the date of randomization
  • Endovascular thrombectomy (EVT) for large vessel occlusion (LVO) in the anterior circulation, according to current guidelines and local standards of clinical care. The definition of LVO may include the intracranial segment of the internal carotid artery (ICA), and/ or the M1 segment (proximal, mid, distal) of the middle cerebral artery (M1-MCA), and/ or the proximal M2 segment of the MCA (M2-MCA)
  • Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), or via a deferred consent process approved by the relevant ethics committee, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

  • Mechanical ventilatory support for acute medical condition prior to procedure (i.e. required for reasons other than procedure)
  • Symptomatic congestive heart failure, chronic obstructive pulmonary disease, or any other medical condition that would make either HoB position inappropriate for patient care in the judgement of the investigator.
  • Any condition, such as but not limited to, agitation/ delirium or severe nausea/ vomiting, that, in the view of the investigator, is expected to significantly impede maintaining the assigned HoB
  • Any condition with life expectancy of less than 3 months
  • Inability to randomize within 1 hour from the end of the EVT

Study Design

Enrollment

2240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Head of bed position of 0-degrees

other: Control Arm

Head of bed position of 30-degrees or greater

Interventions

Head of bed position of 0-degrees

Flat position with the HoB at 0° elevation for a continuous 24-hour period. Turning to the side (left or right) is permitted, as long as there is no head elevation.

Head of bed position of 30-degrees or greater

Semi-recumbent position with the HoB to at least 30 degrees for a continuous 24-hour period.

Head and torso must remain elevated at 30 degrees or higher, using the hospital bed's positioning system.

Primary outcome measure

  • Functional disability [ Time Frame: 90±14 days from randomization ]

Central Contacts and Locations

Central contacts

Samantha Block, BSc

905-521-2100hobit@phri.ca

Amanda Taylor, BSc

905-521-2100hobit@phri.ca

Locations

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada, P3E5J1

Contacts

Mythili Velma

705-523-7100mvelma@hsnri.ca

Principal Investigator:

Aviraj Deshmukh, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Kanchana Ratnayake

905-521-2100ratnayake@hhsc.ca

Principal Investigator:

Aristeidis Katsanos, MD

More Information

Sponsor

Population Health Research Institute

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

  • head of bed
  • stroke
  • large vessel occlusion
  • endovascular thrombectomy
  • EVT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.