Healthcare Failure Mode and Effect Analysis in nursing risk management for emergency surgery in spontaneous subarachnoid hemorrhage: a randomized controlled trial

Spontaneous subarachnoid hemorrhage (sSAH) is a severe neurological emergency. The aim of this study was to evaluate whether Healthcare Failure Mode and Effect Analysis (HFMEA)-based nursing risk management reduces the incidence of perioperative nursing adverse events in sSAH patients undergoing emergency surgery. This parallel-group, 1:1 allocation ratio randomized controlled trial was conducted from March 2022 to March 2024. Patients were randomly assigned using computer-generated random number tables with sealed opaque envelopes. The primary outcome was the incidence of perioperative nursing adverse events (composite of rebleeding, cerebral vasospasm, increased intracranial pressure, seizures, pulmonary infection, pressure ulcers, deep vein thrombosis, catheter-related infections, falls/bed exits, and medication errors). Secondary outcomes included nursing quality scores, patient/family satisfaction, length of hospital stay, and 30-day mortality. Subgroup analyses were performed according to surgical method such as aneurysm clipping vs. endovascular coiling and Hunt-Hess grade such as I-II vs. III-V. The intervention group demonstrated a significantly lower incidence of nursing adverse events compared to the control group (6.41% [5/78] vs. 20.51% [16/78]; risk difference: -14.1% [95% CI: -24.2% to -4.0%]; relative risk: 0.31 [95% CI: 0.12–0.82]; P = 0.008). The intervention group showed significantly superior nursing quality scores across all dimensions and higher patient and family satisfaction (all P < 0.001). The intervention group was associated with shorter length of hospital stays (mean difference: -3.7 days [95% CI: -5.0 to -2.4 days]; P < 0.05), while there was no significant difference in 30-day mortality between groups (P > 0.05). Subgroup analyses suggested potential benefits across surgical methods and Hunt-Hess grades, though the interaction test for grade was not statistically significant (P for interaction = 0.082). HFMEA-based nursing risk management effectively reduced perioperative nursing adverse events in sSAH patients. This study provides preliminary RCT evidence for HFMEA in neurosurgical emergency care. The finding that HFMEA may be particularly beneficial in high-risk patients (Hunt-Hess III-V) is hypothesis-generating and requires confirmation in adequately powered studies. Trial registration: ClinicalTrials.gov Identifier: NCT07315048 ( https://clinicaltrials.gov/study/NCT07315048?term=NCT07315048&rank=1 ) (Retrospectively registered on January 2, 2026).