Spontaneous Subarachnoid HemorrhageNCT07315048
Nursing Risk Management in Emergency SAH Surgery Using Healthcare Failure Mode and Effect Analysis(HFMEA)
A study testing HFMEA-based nursing-risk programme in people with Spontaneous Subarachnoid Hemorrhage, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spontaneous Subarachnoid Hemorrhage
- What is being tested?
- HFMEA-based nursing-risk programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Being tested
- HFMEA-based nursing-risk programme
- Keywords
- Healthcare Failure Mode and Effect Analysis, Nursing Risk Management, Emergency Surgery, Patient Safety
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFMEA-based nursing-risk programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 30 days
Family Satisfaction Degree
Family satisfaction questionnaire assessing overall satisfaction with nursing services.
Measured: 30 days
Length of Hospital Stay
Days from admission to discharge.
Measured: 30 days
30-day Mortality
All-cause mortality within 30 days postoperatively.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Mar 2022
- Primary completion30 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315048
- Sponsor's protocol ID
- WestChinaH-HX-2025-04
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Healthcare Failure Mode and Effect Analysis in Nursing Risk Management of Emergency Surgery for Patients With Spontaneous Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT07315048
- Acronym / sponsor ID
- WestChinaH-HX-2025-04
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Keywords
- Healthcare Failure Mode and Effect Analysis, Nursing Risk Management, Emergency Surgery, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: HFMEA-based nursing-risk programmePatients 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: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFMEA-based nursing-risk programmeAlongside 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. | Behavioural | Intervention group |
Primary outcome
perioperative nursing adverse event
Time frame: 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.
5 secondary outcomes
Nursing Quality Score
Time frame: 30 days
Patient Satisfaction Score
Time frame: 30 days
Family Satisfaction Degree
Time frame: 30 days
Length of Hospital Stay
Time frame: 30 days
30-day Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFMEA-based nursing-risk programme in people with Spontaneous Subarachnoid Hemorrhage, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative nursing adverse event (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.