Nurse-Led Predictive Protocol Cuts Neuro-Endovascular Complications

NCT ID: NCT07304973

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-30

Brief Summary

The goal of this prospective cohort study was to develop and test a 12-item, nurse-led predictive checklist that can quickly identify patients at high risk for neurological complications (bleeding, re-blockage, brain swelling, etc.) after endovascular therapy (EVT) for stroke or unruptured aneurysms. The main questions it aims to answer are:

Does the checklist accurately flag complications (sensitivity/specificity)? Does its use shorten the time between first abnormal sign and physician action? Does it lower the rate of severe complications or death and shorten hospital stay? Researchers compared 213 patients managed with the checklist (intervention group) to 213 patients who received standard nursing observation (control group).

Participants were:

Assessed by nurses at 6, 12, 24, and 48 hours post-EVT with the checklist (intervention) or usual monitoring (control) Followed for 7 days for any neurological complication and for 30 days for severe outcomes Checked with urgent CT/MRI and treated whenever the checklist score indicated high risk (≥4/12 points)

Conditions

Endovascular Therapy; Neurological Complications

Keywords

Predictive nursing; Nurse-led checklist; Early intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Nurses used the predictive checklist to assess patients at 6 hours, 12 hours, 24 hours, and 48 hours postprocedural. For each assessment, items were scored as "positive" (1 point) or "negative" (0 point). A total score ≥4 points was defined as high risk, triggering immediate actions: (1) increased monitoring frequency (vital signs every 15 minutes, neurological assessment every 1 hour); (2) urgent cranial CT/MRI scan; (3) notification of the neurointerventional team within 10 minutes; (4) initiation of targeted interventions (e.g., blood pressure control, anti-edema therapy) as per protocol.

Group Type: EXPERIMENTAL

predictive checklist

Intervention Type: OTHER

Nurses used the predictive checklist to assess patients at 6 hours, 12 hours, 24 hours, and 48 hours postprocedural. For each assessment, items were scored as "positive" (1 point) or "negative" (0 point). A total score ≥4 points was defined as high risk, triggering immediate actions: (1) increased monitoring frequency (vital signs every 15 minutes, neurological assessment every 1 hour); (2) urgent cranial CT/MRI scan; (3) notification of the neurointerventional team within 10 minutes; (4) initiation of targeted interventions (e.g., blood pressure control, anti-edema therapy) as per protocol.

Control group

Patients received standard post-EVT care, including vital sign monitoring (every 15-30 minutes for the first 6 hours, then every 1-2 hours), neurological assessment (every 4 hours), and routine laboratory and imaging examinations (e.g., cranial CT at 24 hours postprocedural). Nurses documented clinical findings in electronic medical records and notified physicians only when obvious abnormalities were detected (e.g., NIHSS score increase ≥4 points, severe hypertension).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

predictive checklist

Nurses used the predictive checklist to assess patients at 6 hours, 12 hours, 24 hours, and 48 hours postprocedural. For each assessment, items were scored as "positive" (1 point) or "negative" (0 point). A total score ≥4 points was defined as high risk, triggering immediate actions: (1) increased monitoring frequency (vital signs every 15 minutes, neurological assessment every 1 hour); (2) urgent cranial CT/MRI scan; (3) notification of the neurointerventional team within 10 minutes; (4) initiation of targeted interventions (e.g., blood pressure control, anti-edema therapy) as per protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years old, underwent EVT for AIS (due to anterior circulation large vessel occlusion) or UIAs (size ≥5 mm)

• had a postoperative stay of ≥48 hours.

Exclusion Criteria

• preprocedural intracranial hemorrhage;
• severe liver or kidney dysfunction;
• coagulation disorders;
• refusal to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhigang Lan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

WestChinaH-HX-2025-01

Identifier Type: -

Identifier Source: org_study_id