A randomized trial of Trendelenburg position for acute moderate ischemic stroke

Hui-Sheng Chen (), Nan-Nan Zhang, Yu Cui, Xiao-Qiu Li, Cheng-Shu Zhou, Yu-Tong Ma, Hong Zhang, Chang-Hao Jiang, Run-Hui Li, Li-Shu Wan, Zhen Jiao, Hong-Bo Xiao, Zhuo Li, Ting-Guang Yan, Duo-Lao Wang and Thanh N. Nguyen
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Hui-Sheng Chen: General Hospital of Northern Theater Command
Nan-Nan Zhang: General Hospital of Northern Theater Command
Yu Cui: General Hospital of Northern Theater Command
Xiao-Qiu Li: General Hospital of Northern Theater Command
Cheng-Shu Zhou: Anshan Changda Hospital
Yu-Tong Ma: Beipiao Central Hospital
Hong Zhang: Fukuang General Hospital of Liaoning Health Industry Group
Chang-Hao Jiang: The Traditional Medicine Hospital of Dalian Lvshunkou
Run-Hui Li: Central Hospital affiliated to Shenyang Medical College
Li-Shu Wan: Dandong First Hospital
Zhen Jiao: Anshan Central Hospital
Hong-Bo Xiao: Anshan Central Hospital
Zhuo Li: Panjin Central Hospital
Ting-Guang Yan: Chaoyang Central Hospital
Duo-Lao Wang: Liverpool School of Tropical Medicine
Thanh N. Nguyen: Boston Medical Center

Nature Communications, 2023, vol. 14, issue 1, 1-7

Abstract: Abstract We aim to explore the effect of head-down position (HDP), initiated within 24 hours of onset, in moderate anterior circulation stroke patients with probable large artery atherosclerosis (LAA) etiology. This investigator-initiated, multi-center trial prospective, randomized, open-label, blinded-endpoint, multi-center and phase-2 trial was conducted in China and completed in 2021. Eligible patients were randomly assigned (1:1) into the HDP group receiving −20° Trendelenburg, or control group receiving standard care according to national guideline. The primary endpoint was proportion of modified Rankin Scale (mRS) of 0 to 2 at 90 days, which is a scale for measuring the degree of disability after stroke. 90-day mRS was assessed by a certified staff member who was blinded to group assignment. A total of 96 patients were randomized (47 in HDP group and 49 in control group) and 94 (97.9%) patients were included in the final analysis: 46 in HDP group and 48 in control group. The proportion of favorable outcome was 65.2% (30/46) in the HDP group versus 50.0% (24/48) in the control group (unadjusted: OR 2.05 [95%CI 0.87-4.82], P = 0.099). No severe adverse event was attributed to HDP procedures. This work suggests that the head-down position seems safe and feasible, but does not improve favorable functional outcome in acute moderate stroke patients with LAA. This trial was registered with ClinicalTrials.gov, NCT03744533.

Date: 2023
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DOI: 10.1038/s41467-023-38313-y

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