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Clinical Trial
. 2025 Sep 1;82(9):905-914.
doi: 10.1001/jamaneurol.2025.2253.

Optimal Head-of-Bed Positioning Before Thrombectomy in Large Vessel Occlusion Stroke: A Randomized Clinical Trial

Anne W Alexandrov  1 , Anne J Shearin  1 , Pitchaiah Mandava  2 , Gabriel Torrealba-Acosta  3 , Cheran Elangovan  1 , Balaji Krishnaiah  1 , Katherine Nearing  1 , Elizabeth Robinson  4 , Cara Guthrie-Chu  5 , Matthew Holzmann  6 , Bryan Fill  7 , Dharti R Trivedi  8 , Alicia Richardson  9 , Sandy Middleton  10   11 , Barbara B Brewer  12 , David S Liebeskind  13 , Nitin Goyal  1   14 , James C Grotta  15 , Andrei V Alexandrov  1   16 ; ZODIAC Investigators
Collaborators, Affiliations
Clinical Trial

Optimal Head-of-Bed Positioning Before Thrombectomy in Large Vessel Occlusion Stroke: A Randomized Clinical Trial

Anne W Alexandrov et al. JAMA Neurol. .

Abstract

Importance: Small studies show that 0° head positioning of patients with large vessel occlusion (LVO) stroke improves penumbral blood flow and clinical stability. Understanding whether 0° head position maintains clinical stability would allow for optimal patient positioning before thrombectomy.

Objective: To determine superiority of 0° over 30° head positioning at maintaining clinical stability in patients with LVO before thrombectomy.

Design, setting, and participants: This was a prospective randomized clinical trial with blinding to study enrollment/end points conducted from May 2018 to November 2023. There were 3 planned interim analyses, and the study was conducted at certified thrombectomy hospitals in the US. Included in this analysis were consecutive consenting individuals with computed tomography (CT) angiography-positive anterior or posterior LVO who were candidates for thrombectomy (baseline mRS 0-1) and had viable penumbra (CT perfusion or Alberta Stroke Program Early Computed Tomography Score ≥6) within 24 hours of stroke onset. Enrollment of systemic thrombolysis more than 15 minutes from consent was discouraged to prevent confounding of head position effects; in addition, patients with disabilities who lacked a legal representative could not participate due to lack of consent.

Interventions: Randomization to 0° or 30° head positioning with monitoring every 10 minutes using the National Institutes of Health Stroke Scale (NIHSS) until movement to a catheterization table.

Main outcome and measures: The primary outcome was worsening of 2 or more NIHSS points before thrombectomy. Safety outcomes included severe neurologic deterioration (worsening ≥4 NIHSS points) before thrombectomy, hospital-acquired pneumonia (HAP) during hospitalization, and all-cause death within 3 months.

Results: Planned enrollment included 182 patients. Before data and safety monitoring board study closure, a total of 92 patients (mean [SD] age, 66.6 [14.4] years; 48 male [52.2%]) were randomized: 45 patients to the group with 0° head positioning and 47 patients to the group with 30° head positioning. Patient characteristics were similar between groups; however, patients with head position at 30° experienced worsening on the NIHSS of 2 points or more, whereas patients with head position at 0° showed score stability (hazard ratio [HR], 34.40; 95% CI, 4.65-254.37; P < .001). One patient with 0° head positioning and 20 patients with 30° head positioning experienced worsening on the NIHSS of 4 points or more during positioning (HR, 23.57; 95% CI, 3.16-175.99; P = .002). No patients developed HAP; all-cause death occurred in 2 patients (4.4%) in the 0° group, compared with 10 patients (21.7%; P = .03) in the 30° group.

Conclusions and relevance: Results suggest that 0° head positioning for patients with acute LVO was a protective maneuver to maintain clinical stability in the prethrombectomy phase while awaiting definitive treatment.

Trial registration: ClinicalTrials.gov Identifier: NCT03728738.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Alexandrov reported receiving a grant from the National Institutes of Health (NIH) during the conduct of the study. Ms Robinson reported that her hospital received per-patient payment support from the NIH during the conduct of the study. Ms Guthrie-Chu reported that her hospital received per-patient payment support from the NIH during the conduct of the study. Mr Holzmann reported that his hospital received per-patient payment support from the NIH for participation in the study. Mr Fill reported that his hospital received per-patient payment support from the NIH during the conduct of the study. Dr Trivedi reported that her institution received per-patient payment support from the NIH during the conduct of the study. Ms Richardson reported that her hospital received per-patient payment support from the NIH during the conduct of the study. Dr Liebeskind reported being a paid coinvestigator on Dr Alexandrov’s NIH grant for service as an imaging core laboratory. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Consolidated Standards of Reporting Trials (CONSORT) Diagram
Primary end point measured in 100% of enrolled individuals. Exploratory 3-month modified Rankin Scale (mRS) score end point had 1 patient lost to follow-up in the 30° group. NIHSS indicates National Institutes of Health Stroke Scale.
Figure 2.
Figure 2.. Change in Clinical Stability Over Time
A, Kaplan-Meier curves of the patients in the 0° and 30° groups for worsening 2 or more points on the National Institutes of Health Stroke Scale (NIHSS). B, Kaplan-Meier curves of the patients in the 0° and 30° groups for worsening 4 or more points on the NIHSS.
See this image and copyright information in PMC

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