Nurse-Led Predictive Protocol Cuts Neuro-Endovascular Complications

Vascular Endovascular Therapy: A Nurse-Led Predictive Nursing Protocol for Neurological Complications-Development, Validation, and Clinical Impact

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)

Study Overview

• Status: Completed
• Conditions: Endovascular Therapy; Neurological Complications
• Intervention / Treatment: Other: predictive checklist

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of the checklist	AUC of the checklist for predicting any neurological complication (HT, reocclusion, MCE, sICH) within 7 days postprocedural. Complications were diagnosed by neurointerventional physicians based on clinical manifestations and imaging findings (CT/MRI).	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days
length of hospital stay		30 days
incidence of severe complications	incidence of severe complications (defined as complications requiring surgical intervention, mechanical ventilation, or leading to death within 30 days);	30 days

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Early intervention; Predictive nursing; Nurse-led checklist
• Other Study ID Numbers: WestChinaH-HX-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol and informed consent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No