Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System

Not Applicable

Recruiting

• Conditions: Stroke, Acute

• Registration Number: NCT05874596
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.

Detailed Description

Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases \> 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome (mRS \> 2) at 3 month.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-05-25
• Study Start: 2023-06-22
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1221

Inclusion Criteria

• Age > 18
• AIS patients receiving EVT within 24 hours of stroke onset
• Written informed consent is obtained

Exclusion Criteria

• Patients refuse to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ratio of favorable functional outcome at 3 month	3 months	Ratio of patients with mRS \> 2 at 3-month follow up

Secondary Outcome Measures

Name	Time	Method
Door to groin puncture time	24 hours	Time interval between admission and groin puncture
Ratio of door to groin puncture time < 90 min	24 hours	Time interval between admission and groin puncture \<90 min
mRS score at 3 month	3 months	mRS score at 3-month follow up
Ratio of hemorrhagic transformation at 24 hour	24 hours	Ratio of hemorrhagic transformation at 24 hour after EVT
Ratio of successful reperfusion	24 hours	Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3
Ratio of good functional outcome at 3 month	3 months	Ratio of patients with mRS \> 1 at 3-month follow up
Mortality at 3 month	3 months	Mortality at 3-month follow up
Ratio of symptomatic intracranial hemorrhage at 24 hour	24 hours	Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT
Ratio of door to groin puncture time < 60 min	24 hours	Time interval between admission and groin puncture \<60 min
Procedural duration	24 hours	Time interval between groin puncture and last time of digital subtraction angiography

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China