Establishment of a Predictive System for Perioperative Risk Assessment and Electronic Flowcharting Response Strategies in Thoracic Surgery

August 20, 2024 updated by: Hengxing Liang
  1. To establish a risk assessment scale for thoracic surgery for the Chinese population, and to classify patients; risk according to the relevant scale;
  2. 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;
  3. 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

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.

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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