Acute Critical Illnesses in Emergency SettingsEWS-BANCT07249151

Early Warning Score Combined With Bedside Assessments: Accelerating Emergency Care To Improve Prognosis

A study testing Optimized ED Bedside Nursing Protocol in people with Acute Critical Illnesses in Emergency Settings and Process Optimization of Early Warning &Amp; Assessment for At-risk Emergency Patients, run by Jun Liu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Brief Summary This study, sponsored by the National Natural Science Foundation of China and conducted at the Emergency Department (ED) of Jiangnan University Affiliated Hospital, aims to optimize emergency care for critically ill patients via combining "early warning scoring" and "bedside rapid assessment". Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Critical Illnesses in Emergency Settings, Process Optimization of Early Warning &Amp; Assessment for At-risk Emergency Patients
What is being tested?: Optimized ED Bedside Nursing Protocol
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteChina
Study dates: 1 May 2024to 16 Sep 2025
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients will be eligible for enrollment if they meet all of the following conditions:
Age between 18 and 80 years at the time of presentation.
Presentation to the emergency department (ED) for acute medical evaluation.
Completion of at least one documented Early Warning Score (EWS) assessment upon ED admission or during the ED stay.

Who cannot join

Patients will be excluded if they meet any of the following criteria:
Do-not-resuscitate (DNR) orders or enrollment in a palliative/comfort care pathway at the time of presentation.
Cardiac arrest upon arrival to the ED (unresponsive, pulseless, requiring resuscitation without return of spontaneous circulation).
Transfer out of the hospital (to another institution or to the operating room for immediate surgery) within 24 hours of ED admission.
History of major cardiac surgery (e.g., coronary artery bypass grafting, valve replacement) or heart transplantation, as these conditions may alter baseline hemodynamics and limit EWS applicability.
Severe chronic organ dysfunction, including:

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End-stage renal disease requiring maintenance dialysis; Severe hepatic insufficiency (Child-Pugh class C or equivalent); Advanced heart failure (New York Heart Association class IV).
Known allergy or contraindication to iodinated contrast media (if relevant laboratory or imaging assessments are required for outcome evaluation).
Pregnancy, due to altered physiological parameters and ethical considerations.
Incomplete or missing clinical records, preventing calculation of EWS or confirmation of study endpoints.
Duplicate enrollment due to repeated ED visits or readmissions during the study period (only the first eligible admission will be included).

Trial locations and contacts

1 site in 1 country.

China1 site

Wuxi Taihu Hospital; Affiliated Hospital of Jiangnan University; Wuxi Binhu District Traditional Chinese Medicine Hospital; Wuxi Xinwu District Traditional Chinese Medicine Hospital
Wuxi, Jiangsu, 214122

Other trials in China

About this study

Official title: A Prospective Observational Study Of Early Warning Score Combined With Bedside Assessments In Accelerating Emergency Care Initiation And Improving Patient Prognosis In The Emergency Department

Why the Study? Delayed identification of emergency patients at high risk of deterioration worsens outcomes; traditional assessments often miss subtle deterioration signs. This study seeks a more efficient assessment approach to help clinicians recognize high-risk patients earlier and start targeted treatment faster.

Eligibility 200-300 participants will be recruited from the hospital's ED for acute diseases (e.g., severe infection, heart failure, trauma). Inclusion: aged 18-80, with informed consent (or family consent if unable to communicate). Exclusion: severe mental illness, non-intervenable terminal illness.

Study Process All participants receive routine emergency care. The research team uses a new combined assessment tool: first a 2-minute bedside rapid assessment (vital signs, consciousness, breathing), then early warning scoring to classify risk. Doctors adjust treatment priority based on results. The team records time from admission to treatment initiation and 72-hour condition changes. No additional invasive procedures/experimental drugs are used, and no extra cost for assessments.

Potential Benefits Participants may get more timely, targeted emergency care (reducing deterioration risk and hospital stay). Study results will improve emergency care at this and other hospitals, benefiting more emergency patients.

Study Leadership Principal Investigator: Dr. Jun Liu (Attending Physician, ED of Jiangnan University Affiliated Hospital) Responsible Party: Jiangnan University Affiliated Hospital (Sponsor) Ethical Approval: Approved by the hospital's Medical Ethics Committee (Approval No.: To be filled with actual number)

Conditions: Acute Critical Illnesses in Emergency Settings, Process Optimization of Early Warning &Amp; Assessment for At-risk Emergency Patients
Being tested: Optimized ED Bedside Nursing Protocol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optimized ED Bedside Nursing ProtocolProcedure or surgery
A 3-minute standardized emergency nursing assessment exclusively performed by frontline ED nurses, integrating modified National Early Warning Score (mNEWS) and structured bedside checks. Implemented immediately after patient admission (pre-treatment initiation), it includes 2-minute evaluations of systolic BP, HR, RR, SpO₂, respiratory status, and GCS score, followed by 1-minute mNEWS calculation to stratify into low/medium/high risk-directly guiding care prioritization. Distinct from unstructured experience-based assessments or physician-led scoring tools, it's tailored for 24/7 shift-based cluster settings across multiple hospitals.

Study groups in NCT07249151
Study group	Role	What they receive
Optimized ED Bedside Nursing Protocol	Experimental	Arm 1 (Intervention: Optimized ED Assessment) 12 clusters (3 hospitals × 6 depts, day/night shifts) randomized to intervention in 10 phases. Participants get "mNEWS + structured bedside rapid assessment" at triage: 3-min standard assessment (2-min checks: BP, HR, RR, SpO₂, GCS, respiratory status; 1-min mNEWS for risk stratification). Staff prioritize treatment via results. Optimized protocol replaces conventional post-randomization. Receives: Procedure: Optimized ED Bedside Nursing Protocol
Control Arm: Conventional Emergency Assessment	No intervention	Control: Conventional ED Assessment Waitlist clusters keep routine assessment pre-randomization. Conventional process: vital sign recording (BP, HR, RR) + subjective severity judgment, no structured scoring/risk stratification. Clusters switch to optimized post-wait, but control data collected only during conventional implementation.

What is being measured

The primary outcome is the main question the study is designed to answer.

ICU-Level Organ Support or In-Hospital Mortality Within 24 Hours
Composite endpoint defined as the occurrence of either "ICU-level organ support" or "in-hospital mortality" within 24 hours after EWS score ≥5 (T0). "ICU-level organ support" includes: invasive mechanical ventilation initiation, continuous vasopressor use for ≥30 minutes, or CRRT activation. "In-hospital mortality" refers to death occurring during the current hospitalization. Data are extracted from electronic medical records (EMR) and ICU information systems, with event time confirmed by the earliest timestamp of organ support initiation or death notification.
Measured: From the time of patient admission (admission time) up to 24 hours after admission time.

Secondary outcomes (5)

T3 Compliance Rate
T3 is a time-limited indicator for the process "Junior Nurse (JN) reporting → Senior Nurse (SN) secondary assessment". The time frame focuses on the maximum observation window (≤10 minutes) of this process, directly linking to the "time limit criteria" for compliance rate.
Measured: Within the first 24 hours from ED registration
Door-to-Key Intervention Time
The core of "door-to-intervention time" is the interval between "registration time → intervention execution time". The time frame covers the complete timing cycle, adapting to the phenotype-stratified intervention logic.intervention execution time". The time frame covers the complete timing cycle, adapting to the phenotype-stratified intervention logic.
Measured: Within the first 24 hours from ED registration
72-Hour ICU Admission Rate
This outcome measure focuses on the rate of ICU admission within the "72-hour post-T0" window. Observation terminates if the patient is discharged from the hospital before 72 hours post-T0 (and no ICU admission occurs during the hospitalization). The unit of measure is a percentage (%).
Measured: From T0 (time of enrollment or index event) until ICU admission or hospital discharge, whichever occurs first, assessed up to 72 hours post-T0.
28-Day In-Hospital Mortality
This outcome measure focuses on in-hospital mortality within the "28-day post-registration" window. Observation terminates at the earlier of two events: ① the patient's death during hospitalization, or ② the patient's discharge from the hospital (if no death occurs during the 28-day post-registration period). The unit of measure is a percentage (%).
Measured: From patient ED registration up to 28 days after registration
Incidence of Over-Escalation and Delayed Escalation
Over-escalation requires a "72-hour observation period to verify intervention necessity", while delayed escalation requires immediate determination of time limit deviation. The time frame aligns with the judgment logic of both events.
Measured: From T0 (initial escalation decision) until confirmation of intervention necessity or time limit deviation, whichever occurs first, assessed up to 72 hours post-T0.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202416 Sep 2025

First posted25 Nov 2025
Study start1 May 2024
Primary completion30 Aug 2025
Study completion16 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Acute Critical Illnesses in Emergency SettingsStudies of the same condition, open and under way.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07249151
Sponsor's protocol ID: AHJN-NURS-20240917
Other IDs: 82302187
Acronym: EWS-BA
Status last verified: Nov 2025
First submitted: 17 Sep 2025
Last updated: 25 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified individual participant data (IPD) are pending final quality inspection, consistency verification, and standardized organization; premature sharing may lead to the use of unvalidated data, thereby compromising the reliability of secondary analyses. The current IPD will support subsequent sub-studies (e.g., disease phenotype-stratified analysis, long-term outcome correlation research). Temporary non-sharing of data prevents the redundant use of core data and ensures the integrity of this research series. Upon completion of the aforementioned tasks (final data verification, implementation of follow-up sub-studies, confirmation of data security), the team will re-evaluate the IPD sharing arrangement. If feasible, the relevant arrangements will be promptly disclosed via ClinicalTrials.gov.

Publications

Covino M, Sandroni C, Della Polla D, De Matteis G, Piccioni A, De Vita A, Russo A, Salini S, Carbone L, Petrucci M, Pennisi M, Gasbarrini A, Franceschi F. Predicting ICU admission and death in the Emergency Department: A comparison of six early warning scores. Resuscitation. 2023 Sep;190:109876. doi: 10.1016/j.resuscitation.2023.109876. Epub 2023 Jun 17.
PubMed 37331563
Churpek MM, Snyder A, Han X, Sokol S, Pettit N, Howell MD, Edelson DP. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911. doi: 10.1164/rccm.201604-0854OC.
PubMed 27649072
Candel BGJ, Nissen SK, Nickel CH, Raven W, Thijssen W, Gaakeer MI, Lassen AT, Brabrand M, Steyerberg EW, de Jonge E, de Groot B. Development and External Validation of the International Early Warning Score for Improved Age- and Sex-Adjusted In-Hospital Mortality Prediction in the Emergency Department. Crit Care Med. 2023 Jul 1;51(7):881-891. doi: 10.1097/CCM.0000000000005842. Epub 2023 Mar 23.
PubMed 36951452
Arevalo-Buitrago P, Morales-Cane I, Olivares Luque E, Godino-Rubio M, Rodriguez-Borrego MA, Lopez-Soto PJ. Early detection of risk for clinical deterioration in emergency department patients: validation of a version of the National Early Warning Score 2 for use in Spain. Emergencias. 2022 Dec;34(6):452-457. English, Spanish.
PubMed 36625695
Nannan Panday RS, Minderhoud TC, Alam N, Nanayakkara PWB. Prognostic value of early warning scores in the emergency department (ED) and acute medical unit (AMU): A narrative review. Eur J Intern Med. 2017 Nov;45:20-31. doi: 10.1016/j.ejim.2017.09.027. Epub 2017 Oct 7.
PubMed 28993097

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational Study Of Early Warning Score Combined With Bedside Assessments In Accelerating Emergency Care Initiation And Improving Patient Prognosis In The Emergency Department
ClinicalTrials.gov ID: NCT07249151
Acronym / sponsor ID: EWS-BA / AHJN-NURS-20240917
Conditions: Acute Critical Illnesses in Emergency Settings, Process Optimization of Early Warning &Amp; Assessment for At-risk Emergency Patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,000 participants (actual)
Lead sponsor: Jun LiuUniversity, hospital or other
Study start: 1 May 2024 (actual)
Primary completion: 30 Aug 2025 (actual)
Study completion: 16 Sep 2025 (actual)
First posted: 25 Nov 2025 (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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Optimized ED Bedside Nursing Protocol	Experimental	Procedure: Optimized ED Bedside Nursing ProtocolArm 1 (Intervention: Optimized ED Assessment) 12 clusters (3 hospitals × 6 depts, day/night shifts) randomized to intervention in 10 phases. Participants get "mNEWS + structured bedside rapid assessment" at triage: 3-min standard assessment (2-min checks: BP, HR, RR, SpO₂, GCS, respiratory status; 1-min mNEWS for risk stratification). Staff prioritize treatment via results. Optimized protocol replaces conventional post-randomization.
Control Arm: Conventional Emergency Assessment	No intervention	–Control: Conventional ED Assessment Waitlist clusters keep routine assessment pre-randomization. Conventional process: vital sign recording (BP, HR, RR) + subjective severity judgment, no structured scoring/risk stratification. Clusters switch to optimized post-wait, but control data collected only during conventional implementation.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age between 18 and 80 years at the time of presentation.
Presentation to the emergency department (ED) for acute medical evaluation.
Completion of at least one documented Early Warning Score (EWS) assessment upon ED admission or during the ED stay.

Key exclusion criteria (11 listed)

Do-not-resuscitate (DNR) orders or enrollment in a palliative/comfort care pathway at the time of presentation.
Cardiac arrest upon arrival to the ED (unresponsive, pulseless, requiring resuscitation without return of spontaneous circulation).
Transfer out of the hospital (to another institution or to the operating room for immediate surgery) within 24 hours of ED admission.
History of major cardiac surgery (e.g., coronary artery bypass grafting, valve replacement) or heart transplantation, as these conditions may alter baseline hemodynamics and limit EWS applicability.
Severe chronic organ dysfunction, including:

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
Optimized ED Bedside Nursing ProtocolA 3-minute standardized emergency nursing assessment exclusively performed by frontline ED nurses, integrating modified National Early Warning Score (mNEWS) and structured bedside checks. Implemented immediately after patient admission (pre-treatment initiation), it includes 2-minute evaluations of systolic BP, HR, RR, SpO₂, respiratory status, and GCS score, followed by 1-minute mNEWS calculation to stratify into low/medium/high risk-directly guiding care prioritization. Distinct from unstructured experience-based assessments or physician-led scoring tools, it's tailored for 24/7 shift-based cluster settings across multiple hospitals.	Procedure or surgery	Optimized ED Bedside Nursing Protocol

Primary outcome

ICU-Level Organ Support or In-Hospital Mortality Within 24 Hours
Time frame: From the time of patient admission (admission time) up to 24 hours after admission time.
Composite endpoint defined as the occurrence of either "ICU-level organ support" or "in-hospital mortality" within 24 hours after EWS score ≥5 (T0). "ICU-level organ support" includes: invasive mechanical ventilation initiation, continuous vasopressor use for ≥30 minutes, or CRRT activation. "In-hospital mortality" refers to death occurring during the current hospitalization. Data are extracted from electronic medical records (EMR) and ICU information systems, with event time confirmed by the earliest timestamp of organ support initiation or death notification.

5 secondary outcomes

T3 Compliance Rate
Time frame: Within the first 24 hours from ED registration
Door-to-Key Intervention Time
Time frame: Within the first 24 hours from ED registration
72-Hour ICU Admission Rate
Time frame: From T0 (time of enrollment or index event) until ICU admission or hospital discharge, whichever occurs first, assessed up to 72 hours post-T0.
28-Day In-Hospital Mortality
Time frame: From patient ED registration up to 28 days after registration
Incidence of Over-Escalation and Delayed Escalation
Time frame: From T0 (initial escalation decision) until confirmation of intervention necessity or time limit deviation, whichever occurs first, assessed up to 72 hours post-T0.

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 25 Nov 2025.
Results publication: PubMed 37331563Covino M, Sandroni C, Della Polla D, De Matteis G, Piccioni A, De Vita A, Russo A, Salini S, Carbone L, Petrucci M, Pennisi M, Gasbarrini A, Franceschi F. Predicting ICU admission and death in the Emergency Department: A comparison of six early warning scores. Resuscitation. 2023 Sep;190:109876. doi: 10.1016/j.resuscitation.2023.109876. Epub 2023 Jun 17.
Results publication: PubMed 27649072Churpek MM, Snyder A, Han X, Sokol S, Pettit N, Howell MD, Edelson DP. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911. doi: 10.1164/rccm.201604-0854OC.
Results publication: PubMed 36951452Candel BGJ, Nissen SK, Nickel CH, Raven W, Thijssen W, Gaakeer MI, Lassen AT, Brabrand M, Steyerberg EW, de Jonge E, de Groot B. Development and External Validation of the International Early Warning Score for Improved Age- and Sex-Adjusted In-Hospital Mortality Prediction in the Emergency Department. Crit Care Med. 2023 Jul 1;51(7):881-891. doi: 10.1097/CCM.0000000000005842. Epub 2023 Mar 23.
Results publication: PubMed 36625695Arevalo-Buitrago P, Morales-Cane I, Olivares Luque E, Godino-Rubio M, Rodriguez-Borrego MA, Lopez-Soto PJ. Early detection of risk for clinical deterioration in emergency department patients: validation of a version of the National Early Warning Score 2 for use in Spain. Emergencias. 2022 Dec;34(6):452-457. English, Spanish.
Results publication: PubMed 28993097Nannan Panday RS, Minderhoud TC, Alam N, Nanayakkara PWB. Prognostic value of early warning scores in the emergency department (ED) and acute medical unit (AMU): A narrative review. Eur J Intern Med. 2017 Nov;45:20-31. doi: 10.1016/j.ejim.2017.09.027. Epub 2017 Oct 7.
Individual participant dataSharing planned: No. De-identified individual participant data (IPD) are pending final quality inspection, consistency verification, and standardized organization; premature sharing may lead to the use of unvalidated data, thereby compromising the reliability of secondary analyses. The current IPD will support subsequent sub-studies (e.g., disease phenotype-stratified analysis, long-term outcome correlation research). Temporary non-sharing of data prevents the redundant use of core data and ensures the integrity of this research series. Upon completion of the aforementioned tasks (final data verification, implementation of follow-up sub-studies, confirmation of data security), the team will re-evaluate the IPD sharing arrangement. If feasible, the relevant arrangements will be promptly disclosed via ClinicalTrials.gov.

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?

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 4 inclusion and 11 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 25 Nov 2025. 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?

ICU-Level Organ Support or In-Hospital Mortality Within 24 Hours (time frame: From the time of patient admission (admission time) up to 24 hours after admission time.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249151, which also lists 5 linked publications.

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 25 Nov 2025.