None listed
Conditions
Brief summary
The purpose of the study is to evaluate the effects of head-down positioning (15 degrees below horizontal) in acute stroke, using both clinical and radiographic outcome measures. Primary Aim: 1) To demonstrate definitively whether body positioning improves cerebral blood flow in acute ischaemic stroke, as measured by CT perfusion imaging Secondary Aims: 1) To demonstrate (in ‘responders’) whether altered body position acutely affects neurologic function 2) To determine (in ‘responders’) whether altered body positioning (15 degrees head down) lessens the likelihood of progression of ‘penumbra’ to infarction, as assessed by 24 hour magnetic resonance imaging.
Interventions
A standard of care CT perfusion scan is performed in all patients, followed by an additional CT perfusion scan (with torso and limbs on a 20 degree angled foam wedge) if a perfusion lesion of >30ML is identified and the patient or proxy consents. Patients who are identified as CT perfusion 'responders' to head positioning (based on the improvement of TMAX>6 (or delay time >3) lesion volume reduction of greater than or equal to 5Ml following repeat CT perfusion ) will be placed in the 15 degree
A standard of care CT perfusion scan is performed in all patients, followed by an additional CT perfusion scan (with torso and limbs on a 20 degree angled foam wedge) if a perfusion lesion of >30ML is identified and the patient or proxy consents. Patients who are identified as CT perfusion 'responders' to head positioning (based on the improvement of TMAX>6 (or delay time >3) lesion volume reduction of greater than or equal to 5Ml following repeat CT perfusion ) will be placed in the 15 degree head down position on a regular hospital barouche for 24 hours, or whenever TICI IIC/III reperfusion is achieved. Non-responders will received normal standard of care positioning. Blood pressure is recorded during both the supine and 'heads down' CT scans. All patients will have an NIHSS score and blood pressure measurement performed by authorised blinded trial staff following 5 minutes of 'heads down' and then 'heads up' position immediately following the scan. The patient is then assigned to 24 hours of positioning based on the CT perfusion findings. The responsibility of maintaining and recording head positioning lies with the stroke specialist nurse who is looking after the patient for the first 24 hours. Post 24 hour NIHSS, 24 hour MRI/A (+/- perfusion) and 90day follow-up is assessed by stroke unit staff and is standard of care.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Acute anterior circulation ischaemic stroke with measurable neurologic deficit 2) Demonstration of penumbra of CT perfusion imaging (TMax lesion (>6 seconds) volume > 30 mL, as measured by RAPID software)
Exclusion criteria
1) Known renal failure (eGFR < 30mL) 2) Posterior circulation stroke with dysphagia 3) Clinically evident or recent (<1 month) left ventricular failure 4) Iodine contrast hypersensitivity 5) Any other contraindication to ‘head down’ position (evident increased respiratory effort, nausea and vomiting) 6) <60 years old 7) High probability of death within the next 48 h 8) Planned early decompressive craniectomy
Outcome results
None listed