- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07065812
- Original Trial
Team Familiarity and Perioperative Outcomes in Non-Cardiac Surgery
The Impact of Team Familiarity on Surgical Outcomes and Patient Safety in Non-Cardiac Surgery
The goal of this retrospective observational study is to quantify the impact of team collaboration on work efficiency in operating room and patient safety outcomes in non-cardiac surgical teams. The main purpose is to answer:
How does team collaboration affect work efficiency in operating room and patient safety outcomes during/after surgery? The data will be obtained from the Hospital Electronic Medical Record Information System, participants already finished all the planned surgeries.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All elective surgeries for adults (age ≥18 years)
Exclusion Criteria:
- Surgeries in which patient demographics (age, gender), ASA grade, procedure details, and positional data were unattainable
- Cardiac surgical procedures (with a fixed surgical team)
- Operations under non-intubated general anesthesia or intravenous anesthesia (primarily diagnostic procedures not requiring close multidisciplinary collaboration)
- Surgical cases with missing data on pre-anesthesia preparation time, anesthesia induction time, and surgical procedure duration
- Surgical cases with missing data on team members' years of experience and gender information.
- Surgical cases with missing data on intra- and post-operative major complications and other safety-related outcome measures
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Team Efficiency
Time Frame: Perioperative
|
The primary outcome measure of this study is surgical team efficiency, which is represented by three time intervals: pre-anesthesia preparation time (from patient entry into the operating room to anesthesia initiation), anesthesia induction time (from anesthesia initiation to surgery start), and surgical duration (from surgery start to surgery end).
These intervals are calculated in minutes using the anesthesia information management system (AIMS), with timestamps recorded in the anesthesia record form within AIMS for the following key events: patient arrival in the operating room, anesthesia initiation, surgery start, surgery conclusion, anesthesia end and patient exit from the operating room.
|
Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood loss
Time Frame: Perioperative
|
The total volume of blood loss during the procedure,measured in milliliters (mL) .
|
Perioperative
|
|
Duration of PACU (Post-Anesthesia Care Unit) stay
Time Frame: Perioperative
|
From admission to discharge from the PACU recorded in minutes/hours
|
Perioperative
|
|
Unplanned ICU admission within 24 hours post-surgery
Time Frame: Perioperative
|
Perioperative
|
|
|
Number of postoperative ICU admissions
Time Frame: Perioperative
|
Perioperative
|
|
|
ICU stay duration recorded in days
Time Frame: Perioperative
|
Perioperative
|
|
|
Unplanned secondary surgery
Time Frame: Perioperative
|
Perioperative
|
|
|
Postoperative infection
Time Frame: Perioperative
|
Perioperative
|
|
|
In-hospital mortality
Time Frame: Perioperative
|
Perioperative
|
|
|
Total hospital stay duration recorded in days
Time Frame: Perioperative
|
Perioperative
|
|
|
Total hospitalization expenses recorded in RMB/CNY
Time Frame: Perioperative
|
Perioperative
|
|
|
Improvement status of the primary diagnosis on the day of discharge
Time Frame: Perioperative
|
Perioperative
|
|
|
Rescue events during hospitalization
Time Frame: Perioperative
|
Perioperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- 2025ZDSYLL172-P01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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