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

Application of Healthcare Failure Mode and Effect Analysis in Nursing Risk Management of Emergency Surgery for Patients With Spontaneous Subarachnoid Hemorrhage

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.

Study Overview

• Status: Completed
• Conditions: Spontaneous Subarachnoid Hemorrhage
• Intervention / Treatment: Behavioral: HFMEA-based nursing-risk programme

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	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.
No Intervention: Control group; The control group received conventional nursing risk management, including: Admission assessment: vital signs monitoring, neurological function assessment, Hunt-Hess grading;; Preoperative nursing: condition observation, psychological care, preoperative preparation;; Postoperative nursing: close monitoring of vital signs, neurological function observation, complication prevention;; Health education: disease knowledge, precautions, rehabilitation guidance;; Discharge guidance: medication instructions, follow-up arrangements, lifestyle recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Patient Safety; Emergency Surgery; Healthcare Failure Mode and Effect Analysis; Nursing Risk Management
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Subarachnoid Hemorrhage
• Other Study ID Numbers: WestChinaH-HX-2025-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No