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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07304973
Enrollment
426
Registered
2025-12-26
Start date
2022-01-01
Completion date
2023-12-30
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovascular Therapy, Neurological Complications

Keywords

Predictive nursing, Nurse-led checklist, Early intervention

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)

Interventions

OTHERpredictive 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.

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
AUC of the checklist7 daysAUC 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).

Secondary

MeasureTime frameDescription
incidence of severe complications30 daysincidence of severe complications (defined as complications requiring surgical intervention, mechanical ventilation, or leading to death within 30 days);
length of hospital stay30 days
30-day mortality30 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026