- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06501157
Establishment of Emergency Surgery Triage and Checklist Management System
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?
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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after implementation
Patients undergoing emergency surgery at Peking Union Medical College Hospital after Emergency Surgery Triage and Checklist Management System
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of omitted information
Time Frame: Outcome will be assessed on the operative day
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The number of omitted information items during the emergency-anesthesia handover.
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Outcome will be assessed on the operative day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient waiting times, including time to theatre and time to incision.
Time Frame: Outcome will be assessed on the operative day
|
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.
|
Outcome will be assessed on the operative day
|
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Feasibility of handover checklist
Time Frame: Outcome will be assessed on the operative day
|
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.
|
Outcome will be assessed on the operative day
|
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In-hospital mortality
Time Frame: From date of admission until discharge, assessed up to 4 weeks
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In-hospital mortality
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From date of admission until discharge, assessed up to 4 weeks
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In-hospital morbidity
Time Frame: From date of admission until discharge, assessed up to 4 weeks
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In-hospital morbidity will be documented and rated using Clavein-Dindo classification system
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From date of admission until discharge, assessed up to 4 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-24PJ1128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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