- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527094
Machine Learning Model to Predict Postoperative Respiratory Failure
August 29, 2022 updated by: Hyun-Kyu Yoon, Seoul National University Hospital
Development and Prospective Evaluation of a Machine Learning Model to Predict Postoperative Respiratory Failure
The main objective of this study is to develop a machine learning model that predicts postoperative respiratory failure within 7 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postoperative pulmonary complications are known to increase the length of hospital stay and healthcare cost.
One of the most serious form of these complications is postoperative respiratory failure, which is also associated with morbidity and mortality.
A lot of risk stratification models have been developed for identifying patients at increased risk of postoperative respiratory failure.
However, these models were built by using a traditional logistic regression analysis.
A logistic regression analysis had disadvantages of assuming the relationship between dependent and independent variables as linear.
Recent advances in artificial intelligence make it possible to manage and analyze big data.
Prediction model using a machine learning technique and large-scale data can improve the accuracy of prediction performance than those of previous models using traditional statistics.
Furthermore, a machine learning technique may be a useful adjuvant tool in making clinical decisions or real-time prediction if it is integrated into the healthcare system.
However, to our knowledge, there was no study investigating the predictive factors of postoperative respiratory failure using a machine-learning approach.
Therefore, the main objective of this study is to develop a machine learning model that predicts postoperative respiratory failure within 7 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes and evaluate its performance prospectively.
Study Type
Observational
Enrollment (Actual)
22250
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
-
-
-
Seoul, Korea, Republic of
- Hyun-Kyu Yoon
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients undergoing general anesthesia for noncardiac surgery
Description
Inclusion Criteria:
- Adults patients undergoing general anesthesia for noncardiac surgery
Exclusion Criteria:
- Age under 18 years
- Surgery duration < 1 hr
- Cardiac surgery
- Surgery performed only regional or local anesthesia, peripheral nerve block, or monitored anesthesia care
- Organ transplantation
- Patient with preoperative tracheal intubation
- Patients who had tracheostoma prior to surgery
- Patients scheduled for tracheostomy
- Surgery performed outside the operating room
- Length of hospital stay < 24 h
If the patients had multiple surgeries during the same hospital stays, we included the first surgical cases in the dataset.
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 |
---|---|
AI_PRF
Adults patients undergoing general anesthesia
|
The performance of a machine learning model to predict postoperative respiratory failure after general anesthesia within postoperative day 7 was tested prospectively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of postoperative respiratory failure after general anesthesia
Time Frame: within postoperative day 7
|
Postoperative respiratory failure which was defined as mechanical ventilation >48 h or any reintubation after surgery
|
within postoperative day 7
|
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)
May 26, 2021
Primary Completion (ACTUAL)
May 25, 2022
Study Completion (ACTUAL)
June 25, 2022
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 21, 2020
First Posted (ACTUAL)
August 26, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI_PRF
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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