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.
A single-center randomized trial of adults patients undergoing emergency repair for ruptured brain aneurysms was trying to determing that if proactive "Healthcare Failure Mode and Effect Analysis" (HFMEA) could lower the rate of nursing-related adverse events from 1 in 5 patients to fewer than 1 in 15. Nurses trained in HFMEA mapped every step of care-from arrival through discharge-identified the 12 highest-risk moments (e.g., delayed pressure checks, missed re-bleeding signs), and built checklists, alert thresholds, and team huddles to stop problems before they started. aim: adding a structured, forward-looking safety drill to routine neuro-critical nursing appears to spare two out of every three avoidable complications after emergency "brain-aneurysm" surgery without extra technology or cost.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
156
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.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
perioperative nursing adverse event
Incidence of perioperative nursing adverse events, including: * Rebleeding * Cerebral vasospasm * Increased intracranial pressure * Seizures * Pulmonary infection * Pressure ulcers * Deep vein thrombosis * Catheter-related infections * Falls/bed exits * Medication errors, etc.
Time frame: 30 days
Nursing Quality Score
Nursing Quality Score: Newcastle Satisfaction with Nursing Scale (NSNS), including four dimensions: condition observation, basic nursing, specialized nursing, and health education, each scored 0-25 points, total score 0-100 points, with higher scores indicating better nursing quality.
Time frame: 30 days
Patient Satisfaction Score
Self-designed satisfaction questionnaire covering nursing attitude, nursing skills, health education, environmental management, using 5-point Likert scale, total score 20-100 points.
Time frame: 30 days
Family Satisfaction Degree
Family satisfaction questionnaire assessing overall satisfaction with nursing services.
Time frame: 30 days
Length of Hospital Stay
Days from admission to discharge.
Time frame: 30 days
30-day Mortality
All-cause mortality within 30 days postoperatively.
Time frame: 30 days
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