Clinical trial NCT05874596: Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System
Official title: Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 1221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ratio of favorable functional outcome at 3 month
timeFrame: 3 months
Secondary outcomes:
measure: Ratio of good functional outcome at 3 month
timeFrame: 3 months
measure: mRS score at 3 month
timeFrame: 3 months
measure: Mortality at 3 month
timeFrame: 3 months
measure: Ratio of hemorrhagic transformation at 24 hour
timeFrame: 24 hours
measure: Ratio of symptomatic intracranial hemorrhage at 24 hour
timeFrame: 24 hours
measure: Door to groin puncture time
timeFrame: 24 hours
measure: Ratio of door to groin puncture time < 90 min
timeFrame: 24 hours
measure: Ratio of door to groin puncture time < 60 min
timeFrame: 24 hours
measure: Procedural duration
timeFrame: 24 hours
measure: Ratio of successful reperfusion
timeFrame: 24 hours
Other outcomes:
measure: Ratio of favorable functional outcome at 3 month in patients within 6 hours of stroke onset
timeFrame: 3 months
measure: Door to groin puncture time in patients within 6 hours of stroke onset
timeFrame: 24 hours
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
Study officials:
affiliation: Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
name: Zexin Chen
role: PRINCIPAL_INVESTIGATOR
References: