Spontaneous Subarachnoid Hemorrhage
Conditions
Keywords
Healthcare Failure Mode and Effect Analysis, Nursing Risk Management, Emergency Surgery, Patient Safety
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALHFMEA-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
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. sSAH confirmed by head CT and/or CT angiography (CTA) or digital subtraction angiography (DSA), with identified intracranial aneurysm; 2. Age 18-75 years; 3. Time from onset to admission ≤72 hours; 4. Undergoing emergency surgical treatment (open aneurysm clipping or endovascular coiling); 5. Hunt-Hess grade I-V; 6. Patient or family consent to participate in the study with signed informed consent.
Exclusion criteria
1. Traumatic subarachnoid hemorrhage; 2. Concurrent other intracranial diseases (e.g., brain tumors, arteriovenous malformations); 3. Severe cardiac, hepatic, or renal dysfunction; 4. Coagulation disorders; 5. History of psychiatric disorders or cognitive impairment; 6. Pregnancy or lactation; 7. Transfer to another hospital or treatment withdrawal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| perioperative nursing adverse event | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nursing Quality Score | 30 days | 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. |
| Patient Satisfaction Score | 30 days | Self-designed satisfaction questionnaire covering nursing attitude, nursing skills, health education, environmental management, using 5-point Likert scale, total score 20-100 points. |
| Family Satisfaction Degree | 30 days | Family satisfaction questionnaire assessing overall satisfaction with nursing services. |
| Length of Hospital Stay | 30 days | Days from admission to discharge. |
| 30-day Mortality | 30 days | All-cause mortality within 30 days postoperatively. |
Countries
China
Outcome results
None listed