- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06566053
Establishment of a Predictive System for Perioperative Risk Assessment and Electronic Flowcharting Response Strategies in Thoracic Surgery
August 20, 2024 updated by: Hengxing Liang
- To establish a risk assessment scale for thoracic surgery for the Chinese population, and to classify patients; risk according to the relevant scale;
- Combining the guidelines for the management of acute and critical illnesses in thoracic surgical care units and the characteristics of diagnosis and treatment operations, to make an AI-assisted diagnosis and treatment process software;
- Evaluate whether the software can provide timely and correct diagnosis and treatment recommendations for critically ill patients, shorten the time for homogenized training of specialist intensivists, and reduce the hospitalization cost of patients under the review of resident training instructors of various specialties.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- The Second Xiangya Hospital of Central South University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University for surgical treatment.
Description
Inclusion Criteria:
- Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University for surgical treatment.
Exclusion Criteria:
- Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University without surgical treatment.
Patients under the age of 18.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients who underwent thoracic surgery
Gender:Both Participant age:18-100 Examples include early-stage non-small cell lung cancer (NSCLC), NSCLC patients who have undergone neoadjuvant therapy, esophageal diseases, mediastinal masses, chest wall disorders, and other related conditions.
|
Observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute Respiratory Distress Syndrome
Time Frame: 2024.8-2024.12
|
ARDS definition was based on the new global definition of ARDS10.
Briefly, intubated ARDS was defined as an oxygenation index of less than 300 under a positive end-expiratory pressure (PEEP) of at least 5 cmH2O, and non-intubated ARDS was defined as patients receiving high-flow nasal oxygen (HFNO) ≥ 30 L/min or noninvasive ventilation/continuous positive airway pressure (NIV/CPAP) with a PEEP of at least 5 cmH2O and meeting PaO2:FiO2 ≤ 300 mm Hg or SpO2:FiO2 ≤ 315 (if SpO2 ≤ 97%).
|
2024.8-2024.12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In hospital mortality
Time Frame: 2024.8-2024.12
|
refers to the number or percentage of patients who die while being treated in a hospital.
|
2024.8-2024.12
|
|
Length of hospital stay
Time Frame: 2024.8-2024.12
|
Length of hospital stay(days): refers to the total number of days a patient spends in the hospital from the time of admission to the time of discharge.
|
2024.8-2024.12
|
|
Length of ICU stay
Time Frame: 2024.8-2024.12
|
Length of ICU stay(hours): refers to the total duration of time a patient spends in the Intensive Care Unit (ICU) during a single admission.
|
2024.8-2024.12
|
|
Length of postoperative stay
Time Frame: 2024.8-2024.12
|
Length of postoperative stay(days): refers to the duration of time a patient remains in the hospital or medical facility after undergoing surgery.
|
2024.8-2024.12
|
|
Duration of mechanical ventilation
Time Frame: 2024.8-2024.12
|
Duration of mechanical ventilation(hours): refers to the length of time a patient requires assistance from a mechanical ventilator to maintain adequate breathing.
|
2024.8-2024.12
|
|
Duration of HFNC
Time Frame: 2024.8-2024.12
|
Duration of HFNC(hours): refers to the length of time that a patient is treated with High-Flow Nasal Cannula (HFNC) therapy.
|
2024.8-2024.12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
May 26, 2024
First Submitted That Met QC Criteria
August 20, 2024
First Posted (Actual)
August 22, 2024
Study Record Updates
Last Update Posted (Actual)
August 22, 2024
Last Update Submitted That Met QC Criteria
August 20, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- LYF2023105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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