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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04527094
Other study ID # AI_PRF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 26, 2021
Est. completion date June 25, 2022

Study information

Verified date August 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22250
Est. completion date June 25, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Prediction of postoperative respiratory failure using a machine learning
The performance of a machine learning model to predict postoperative respiratory failure after general anesthesia within postoperative day 7 was tested prospectively.

Locations

Country Name City State
Korea, Republic of Hyun-Kyu Yoon Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of postoperative respiratory failure after general anesthesia Postoperative respiratory failure which was defined as mechanical ventilation >48 h or any reintubation after surgery within postoperative day 7
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