Prediction of Endotracheal Tube Depth by Using Deep Convolutional Neural Networks

October 6, 2021 updated by: Po Jui Chen, Chang Gung Memorial Hospital

The Prediction of Proper Depth of Endotracheal Tube Fixation Before Intubation by Using Deep Convolutional Neural Networks and Chest Radiographs

Malposition of an endotracheal tube (ETT) may lead to a great disaster. Developing a handy way to predict the proper depth of ETT fixation is in need. Deep convolutional neural networks (DCNNs) are proven to perform well on chest radiographs analysis. The investigators hypothesize that DCNNs can also evaluate pre-intubation chest radiographs to predict suitable ETT depth and no related studies are found. The authors evaluated the ability of DCNNs to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation before intubation.

Study Overview

Detailed Description

This was a retrospective, IRB-approved study using chest radiographs images obtained from Picture Archive and Communication System (PACS) at Chang Gung Memorial Hospital, Linkou branch, Taiwan.

A total of 595 de-identified patients' chest radiographs was obtained for this study. The inclusion criteria for this study are patients 18 years or older who were orotracheal intubated within November 2019 to October 2020 and had taken chest radiographs before and immediately after the intubation (<24 hours). Both pre-intubation and post-intubation chest radiographs of a same patient were obtained. Clinical data including age, sex, body height, body weight, depth of ETT fixation were also recorded. All ETT tip to carina distance was manually measured by a same anesthesiologist from post-intubation films and documented. Lip to carina length of each patient can be calculated by adding ETT fixation depth and ETT tip to carina distance.

Pre-intubation chest radiographs (n=595) along with clinical data including age, sex, body height, body weight, and measured lip to carina length are collected for model building. For this study, 476/595 (80%) of those were used for training and 119/595 (20%) for validation randomly selected by AI model. In training process, images and related clinical data along with the measured lip to carina length are fed into and used to fit out AI model. Then, in validation process, the investigators evaluate the model accuracy and efficacy of predicting the lip to carina length with images and clinical data of those unforeseen cases.

Study Type

Observational

Enrollment (Actual)

595

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

    • Guishan Township
      • Taoyuan, Guishan Township, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou Branch

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

Probability Sample

Study Population

Patients 18 years or older who were orotracheal intubated at Chang Gung Memorial Hospital, Linkou branch, Taiwan.

Description

Inclusion Criteria:

  • 18 years or older
  • orotracheal intubated within November 2019 to October 2020
  • had taken chest radiographs before and within 24hr after intubation

Exclusion Criteria:

  • Bad chest radiographs quality that patients' carina can not be recognized
  • Patient with bronchial insertions found in post-intubation films
  • Nasal intubation

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
Training
Images and related clinical data along with the measured lip to carina length of the training group are fed into and used to fit out deep convolutional neural networks model.
using Deep convolutional neural networks to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation
Validation
We evaluate the model accuracy and efficacy of predicting the lip to carina length with images and clinical data of those unforeseen cases in the validation group.
using Deep convolutional neural networks to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The lip to carina length predicted by AI model
Time Frame: 1 minute after DCNNs analysis
The mean absolute error of AI-predicted length in comparison with measured length is used to evaluate AI performance
1 minute after DCNNs analysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of endotracheal tube malpositioning according to AI model recommendation
Time Frame: 1 minute after DCNNs analysis
Endotracheal tube malpositioning is used to elevate the safty of AI recommendation.
1 minute after DCNNs analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2019

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 202002007B0

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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