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

NCT07315048 | Completed DMC

• 1 other identifier: WestChinaH-HX-2025-04
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Subarachnoid Hemorrhage

Keywords

Healthcare Failure Mode and Effect Analysis; Nursing Risk Management; Emergency Surgery; Patient Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nursing Quality Score

  30 days

• Patient Satisfaction Score

  30 days

• Family Satisfaction Degree

  30 days

• Length of Hospital Stay

  30 days

• 30-day Mortality

  30 days

Study Arms (2)

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.

Behavioral: HFMEA-based nursing-risk programme

Control group

NO INTERVENTION

The control group received conventional nursing risk management, including: 1. Admission assessment: vital signs monitoring, neurological function assessment, Hunt-Hess grading; 2. Preoperative nursing: condition observation, psychological care, preoperative preparation; 3. Postoperative nursing: close monitoring of vital signs, neurological function observation, complication prevention; 4. Health education: disease knowledge, precautions, rehabilitation guidance; 5. Discharge guidance: medication instructions, follow-up arrangements, lifestyle recommendations.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sSAH confirmed by head CT and/or CT angiography (CTA) or digital subtraction angiography (DSA), with identified intracranial aneurysm;
• Age 18-75 years;
• Time from onset to admission ≤72 hours;
• Undergoing emergency surgical treatment (open aneurysm clipping or endovascular coiling);
• Hunt-Hess grade I-V;
• Patient or family consent to participate in the study with signed informed consent.

You may not qualify if:

• Traumatic subarachnoid hemorrhage;
• Concurrent other intracranial diseases (e.g., brain tumors, arteriovenous malformations);
• Severe cardiac, hepatic, or renal dysfunction;
• Coagulation disorders;
• History of psychiatric disorders or cognitive impairment;
• Pregnancy or lactation;
• Transfer to another hospital or treatment withdrawal.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 2, 2026
• Study Start: March 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: April 1, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)