Completed

NCT Number: NCT07249151

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

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".

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)

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Key information

Conditions

Acute Critical Illnesses in Emergency Settings Process Optimization of Early Warning &Amp; Assessment for At-risk Emergency Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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:

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).

Treatment and study plan

Optimized ED Bedside Nursing Protocol

Procedure

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.

Primary outcomes

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.

Secondary outcomes

T3 Compliance Rate

Time frame: Within the first 24 hours from ED registration

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.
Door-to-Key Intervention Time

Time frame: Within the first 24 hours from ED registration

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.
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.

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 (%).
28-Day In-Hospital Mortality

Time frame: From patient ED registration up to 28 days after registration

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 (%).
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.

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.

Sponsors and collaborators

Lead sponsor

Jun Liu

Other

Registry information

Official study 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

Acronym: EWS-BA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 25, 2025
Registry last updated: Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.