- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07065812
- Original Trial
Operating Room Team Familiarity and Perioperative Outcomes in Non-Cardiac Surgery
The Impact of Operating Room Team Familiarity on Perioperative Efficiency and Patient Safety Outcomes in Non-Cardiac Surgery
The goal of this retrospective observational cohort study is to investigate the association between operating room team familiarity and perioperative outcomes in non-cardiac surgery.
The operating room team includes surgeons, anesthesiologists, and operating room nurses. Team familiarity will be quantified using the Intraoperative Familiarity Score (IFS), which is calculated based on historical collaboration frequency among team members.
The study will evaluate whether different levels of operating room team familiarity are associated with operating room efficiency indicators and patient safety outcomes.
Data will be obtained from electronic medical records, anesthesia information management systems, and surgical databases of patients who underwent non-cardiac surgery at Zhongda Hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This retrospective observational cohort study investigates the association between operating room team familiarity and perioperative outcomes in non-cardiac surgery.
The operating room team consists of surgeons, anesthesiologists, and operating room nurses. Operating room team familiarity is quantified using the Intraoperative Familiarity Score (IFS), which reflects the historical collaboration frequency among team members involved in surgical procedures.
The IFS is calculated based on the historical frequency of collaboration among all possible pairs of operating room team members, including surgeons, anesthesiologists, and operating room nurses. For each surgical procedure, previous working relationships among participating team members are assessed using historical surgical records. The IFS represents the overall familiarity level of the operating room team, with higher IFS values indicating greater familiarity among team members.
The primary objective of this study is to evaluate whether operating room team familiarity is associated with operating room efficiency. Operating room efficiency will be assessed using workflow time intervals, including pre-anesthesia preparation time, anesthesia induction time, and surgical duration.
Secondary objectives are to evaluate the association between operating room team familiarity and perioperative patient safety outcomes and healthcare utilization outcomes. These outcomes include intraoperative blood loss, postoperative intensive care unit admission, duration of intensive care unit stay, unplanned secondary surgery, unplanned hospital readmission, in-hospital mortality, length of hospital stay, and total hospitalization cost.
Additional analyses will evaluate whether operating room team composition characteristics, including team size and personnel changes during surgical procedures, influence perioperative outcomes or modify the association between team familiarity and clinical outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Southeast University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
• Adult patients (age ≥18 years) undergoing elective non-cardiac surgical procedures at Zhongda Hospital Southeast University between January 1, 2016 and March 31, 2025.
Exclusion Criteria:
- Cardiac surgical procedures.
- Emergency surgical procedures.
- Procedures performed under non-intubated general anesthesia or intravenous anesthesia without airway management and requiring limited multidisciplinary operating room collaboration.
- Surgical procedures with unavailable key perioperative time data, including pre-anesthesia preparation time, anesthesia induction time, or surgical duration.
- Surgical procedures with unavailable information regarding operating room team composition, including participating surgeons, anesthesiologists, or operating room nurses.
- Surgical procedures with missing data for the primary or secondary outcome measures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Non-Cardiac Surgery Cohort
Adult patients undergoing elective non-cardiac surgery.
Operating room team familiarity will be quantified using the Intraoperative Familiarity Score (IFS), and its association with perioperative outcomes will be evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operating Room Team Efficiency
Time Frame: During the index surgical procedure, assessed up to 24 hours
|
Operating room team efficiency is assessed by three workflow time intervals:
All time intervals are measured in minutes based on timestamps recorded in the anesthesia information management system. |
During the index surgical procedure, assessed up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated Intraoperative Blood Loss
Time Frame: During the index surgical procedure, assessed up to 24 hours
|
Total estimated blood loss during surgery, recorded in milliliters (mL) from anesthesia and surgical records.
|
During the index surgical procedure, assessed up to 24 hours
|
|
Duration of Post-Anesthesia Care Unit (PACU) Stay
Time Frame: From transfer from the operating room to the PACU until transfer from the PACU to the ward after the index surgery, assessed up to 12 hours
|
The duration of PACU stay, defined as the time interval from admission to discharge from the post-anesthesia care unit, recorded in minutes.
|
From transfer from the operating room to the PACU until transfer from the PACU to the ward after the index surgery, assessed up to 12 hours
|
|
Postoperative ICU Admission
Time Frame: From completion of the index surgical procedure until hospital discharge, assessed up to 90 days
|
Whether the participant was admitted to the intensive care unit after the index surgery (yes/no), including direct transfer from the operating room to the ICU without PACU recovery, identified from postoperative medical records.
|
From completion of the index surgical procedure until hospital discharge, assessed up to 90 days
|
|
Duration of ICU Stay
Time Frame: From postoperative ICU admission until ICU discharge or transfer to the ward during the index hospitalization (recorded as 0 days if no ICU admission), assessed up to 90 days
|
Length of postoperative ICU stay in days.
Participants not admitted to the ICU are recorded as 0 days; for those admitted (including direct transfer from the operating room to the ICU), duration is measured from ICU admission until ICU discharge or transfer to the ward.
|
From postoperative ICU admission until ICU discharge or transfer to the ward during the index hospitalization (recorded as 0 days if no ICU admission), assessed up to 90 days
|
|
Unplanned Secondary Surgery Within 31 Days After Surgery
Time Frame: From the day of the index surgical procedure, assessed up to 31 days
|
Occurrence of an unplanned secondary surgical procedure within 31 days after the index surgery, identified from hospital surgical records.
|
From the day of the index surgical procedure, assessed up to 31 days
|
|
In-Hospital Mortality
Time Frame: From the day of the index surgical procedure until hospital discharge, assessed up to 90 days
|
Death occurring during the index hospitalization after surgery, identified from hospital medical records.
|
From the day of the index surgical procedure until hospital discharge, assessed up to 90 days
|
|
Unplanned Hospital Readmission Within 31 Days After Surgery
Time Frame: From the day of the index surgical procedure, assessed up to 31 days
|
Occurrence of an unplanned hospital readmission within 31 days after the index surgical procedure, defined as an unexpected inpatient admission after discharge from the index hospitalization and identified from hospital medical records.
|
From the day of the index surgical procedure, assessed up to 31 days
|
|
Length of Hospital Stay
Time Frame: From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
Total duration of hospitalization, measured in days, from hospital admission to discharge after the index surgical procedure.
|
From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
|
Total Hospitalization Cost
Time Frame: From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
Total hospitalization expenses associated with the index surgical procedure, recorded in Chinese Yuan (CNY) based on hospital billing records.
|
From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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.