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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients assigned to the intervention arm received every element of conventional emergency neurosurgical care plus a structured, prospective safety overlay derived from Healthcare Failure Mode and Effect Analysis. The add-on programme was delivered by a nine-member, hospital-authorised HFMEA team (one chief neurosurgeon, two attending neurosurgeons, one head nurse, four bedside nurses, one quality-manager) who had completed an 8-hour training course on HFMEA principles, risk-priority-number (RPN) scoring and decision-tree analysis. The programme ran from the minute the participant arrived in the emergency department until 30-days post-operation and consisted of six sequential steps that were re-applied every month. |
|
| Control group | No Intervention | The control group received conventional nursing risk management, including:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFMEA-based nursing-risk programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative nursing adverse event | Incidence of perioperative nursing adverse events, including:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 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. |
| 30 days |
| Family Satisfaction Degree | Family satisfaction questionnaire assessing overall satisfaction with nursing services. | 30 days |
| Length of Hospital Stay | Days from admission to discharge. | 30 days |
| 30-day Mortality | All-cause mortality within 30 days postoperatively. | 30 days |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |