Emergency SurgeryNCT06501157
Establishment of Emergency Surgery Triage and Checklist Management System
An observational study of Emergency Surgery and Triage, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this observational study is to develop and test a system for managing emergency surgery patients at Beijing Union Medical College Hospital. The main questions it aims to answer are: What information is necessary for effective patient triage and handovers between the emergency department, anesthesia, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Surgery, Triage, Checklist
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled for emergency surgery at Peking Union Medical College Hospital
Who may be able to join
- Patients scheduled for emergency surgery.
- Patients whose condition is critical before surgery, requiring admission to the resuscitation room, emergency observation, or other hospital wards for treatment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Establishment of Emergency Surgery Triage and Checklist Management System--A Mixed Method Study
The goal of this observational study is to develop and test a system for managing emergency surgery patients at Beijing Union Medical College Hospital. The main questions it aims to answer are:
What information is necessary for effective patient triage and handovers between the emergency department, anesthesia, and ICU for surgical patients? How effective and feasible is a standardized handover process in improving patient outcomes and safety?
Read more
Participants will:
Be observed and have their handovers documented to identify key information required.
Participate in implementing a new handover checklist and triage system.
Researchers will compare the periods before and after implementing the new system to see if it:
Reduces missed critical information during handovers. Decreases pre-surgery waiting times for critically ill patients. Improves overall patient safety and outcomes, including reducing postoperative complications, mortality rates, length of hospital stay, and medical costs.
Read the detailed description
The study will be conducted in several phases to establish a comprehensive emergency surgery triage and checklist management system at Beijing Union Medical College Hospital.
Phase 1: Literature Review and Initial Assessment First, a comprehensive review of existing literature and past emergency surgery cases will be conducted to identify common issues and best practices.
Phase 2: Expert Panel and Delphi Process An expert panel consisting of hospital management staff, anesthesiologists, emergency surgeons, ICU intensivists, and ER doctors will be formed. This panel will engage in a Delphi process to discuss and develop a standardized system for managing emergency surgery patients.
Phase 3: System Implementation and Testing
The newly developed system will be implemented and tested. Key metrics to be documented, evaluated, and compared include:
The number of omitted information items during the emergency-anesthesia handover.
Staff satisfaction with the new handover process across the emergency department, general surgery, anesthesia, and ICU.
In-hospital mortality rate after surgery. Postoperative in-hospital complications, classified by Clavien-Dindo grading, and their incidence rate.
Patient waiting times, including time to theatre and time to incision. Duration of the handover process. Incidence of follow-up calls to inquire about additional information after the handover.
Phase 4: Evaluation and Comparison The effectiveness and feasibility of the new system will be evaluated by comparing the collected data before and after its implementation. This comparison will help determine the system\'s impact on improving patient outcomes, safety, and staff efficiency.
By systematically addressing the critical points of patient handovers and emergency surgery management, this study aims to enhance overall healthcare quality and patient safety in emergency surgical settings.
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| after implementation | Patients undergoing emergency surgery at Peking Union Medical College Hospital after Emergency Surgery Triage and Checklist Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of omitted information
The number of omitted information items during the emergency-anesthesia handover.
Measured: Outcome will be assessed on the operative day
Secondary outcomes (4)
Patient waiting times, including time to theatre and time to incision.
Time to Theatre (TTT): This is defined as the duration from when it is determined that the patient needs surgery to the time the patient arrives at the operating theatre. Time to Knife (TTK): This is defined as the duration from when the patient enters the operating theatre to the time the first incision is made.
Measured: Outcome will be assessed on the operative day
Feasibility of handover checklist
Staff satisfaction with the new handover process across the emergency department, general surgery, anesthesia, and ICU. Whether the handover checklist is considered necessary will and feasible will be assessed using a 5 point Likert scale.
Measured: Outcome will be assessed on the operative day
In-hospital mortality
In-hospital mortality
Measured: From date of admission until discharge, assessed up to 4 weeks
In-hospital morbidity
In-hospital morbidity will be documented and rated using Clavein-Dindo classification system
Measured: From date of admission until discharge, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency SurgeryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501157
- Sponsor's protocol ID
- I-24PJ1128
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Emergency Surgery Triage and Checklist Management System--A Mixed Method Study
- ClinicalTrials.gov ID
- NCT06501157
- Acronym / sponsor ID
- I-24PJ1128
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Jul 2024 (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 goal of this observational study is to develop and test a system for managing emergency surgery patients at Beijing Union Medical College Hospital. The main questions it aims to answer are:
What information is necessary for effective patient triage and handovers between the emergency department, anesthesia, and ICU for surgical patients? How effective and feasible is a standardized handover process in improving patient outcomes and safety?
Participants will:
Be observed and have their handovers documented to identify key information required.
Participate in implementing a new handover checklist and triage system.
Researchers will compare the periods before and after implementing the new system to see if it:
Reduces missed critical information during handovers. Decreases pre-surgery waiting times for critically ill patients. Improves overall patient safety and outcomes, including reducing postoperative complications, mortality rates, length of hospital stay, and medical costs.
Detailed description
The study will be conducted in several phases to establish a comprehensive emergency surgery triage and checklist management system at Beijing Union Medical College Hospital.
Phase 1: Literature Review and Initial Assessment First, a comprehensive review of existing literature and past emergency surgery cases will be conducted to identify common issues and best practices.
Phase 2: Expert Panel and Delphi Process An expert panel consisting of hospital management staff, anesthesiologists, emergency surgeons, ICU intensivists, and ER doctors will be formed. This panel will engage in a Delphi process to discuss and develop a standardized system for managing emergency surgery patients.
Phase 3: System Implementation and Testing
The newly developed system will be implemented and tested. Key metrics to be documented, evaluated, and compared include:
The number of omitted information items during the emergency-anesthesia handover.
Staff satisfaction with the new handover process across the emergency department, general surgery, anesthesia, and ICU.
In-hospital mortality rate after surgery. Postoperative in-hospital complications, classified by Clavien-Dindo grading, and their incidence rate.
Patient waiting times, including time to theatre and time to incision. Duration of the handover process. Incidence of follow-up calls to inquire about additional information after the handover.
Phase 4: Evaluation and Comparison The effectiveness and feasibility of the new system will be evaluated by comparing the collected data before and after its implementation. This comparison will help determine the system\'s impact on improving patient outcomes, safety, and staff efficiency.
By systematically addressing the critical points of patient handovers and emergency surgery management, this study aims to enhance overall healthcare quality and patient safety in emergency surgical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| after implementation | – | –Patients undergoing emergency surgery at Peking Union Medical College Hospital after Emergency Surgery Triage and Checklist Management System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for emergency surgery at Peking Union Medical College Hospital
Key inclusion criteria (2 listed)
- Patients scheduled for emergency surgery.
- Patients whose condition is critical before surgery, requiring admission to the resuscitation room, emergency observation, or other hospital wards for treatment.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of omitted information
Time frame: Outcome will be assessed on the operative day
The number of omitted information items during the emergency-anesthesia handover.
4 secondary outcomes
Patient waiting times, including time to theatre and time to incision.
Time frame: Outcome will be assessed on the operative day
Feasibility of handover checklist
Time frame: Outcome will be assessed on the operative day
In-hospital mortality
Time frame: From date of admission until discharge, assessed up to 4 weeks
In-hospital morbidity
Time frame: From date of admission until discharge, assessed up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Emergency Surgery and Triage, run by Peking Union Medical College 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
The number of omitted information (time frame: Outcome will be assessed on the operative day). 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 6 Mar 2025.