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Nursing Risk Management in Emergency SAH Surgery Using Healthcare Failure Mode and Effect Analysis(HFMEA)

NCT07315048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-01-02

No results posted yet for this study

Summary

The investigators are testing whether a new nurse-led safety program (HFMEA) lowers problems during emergency brain-aneurysm surgery better than usual care.

Adults with a sudden brain bleed (subarachnoid hemorrhage) who need urgent clipping or coil placement at the hospital are randomly placed in one of two groups:

Usual nursing care, or Usual care plus HFMEA (nurses use checklists to spot and prevent risks such as re-bleeding, high brain pressure, infection, seizures).

The investigators count how often any nursing-related problems happen within 30 days after surgery, how long patients stay, and how satisfied the participants and their families are.

Results will show if this extra safety program should become standard practice.

Conditions

  • Spontaneous Subarachnoid Hemorrhage

Interventions

BEHAVIORAL

HFMEA-based nursing-risk programme

Alongside standard care, these patients were managed with an HFMEA-based safety bundle. A trained nine-member team had pre-identified 12 highest-risk failure points (delayed ICP checks, missed re-bleeding signs, vasospasm, seizures, infection, etc.). From admission to day-30, nurses followed printed checklists and electronic order-sets: neuro-vitals every 15-30 min, BP target 140-160 mmHg, daily TCDs, automatic "red-flag" escalation for sudden headache/GCS drop, Triple-H protocol for velocities \>120 cm/s, prophylactic levetiracetam for severe grades, 30° head positioning, chlorhexidine/line bundles, pain-delirium scale, bed-alarm, SBAR hand-over and a 5-minute family video with teach-back. Compliance was tracked in real time and reviewed monthly; measures were updated if failure rates did not fall within six weeks.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-03-30
Completion
2024-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315048 on ClinicalTrials.gov