- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05085743
Prediction of Endotracheal Tube Depth by Using Deep Convolutional Neural Networks
The Prediction of Proper Depth of Endotracheal Tube Fixation Before Intubation by Using Deep Convolutional Neural Networks and Chest Radiographs
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guishan Township
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Taoyuan, Guishan Township, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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using Deep convolutional neural networks to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation
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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.
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using Deep convolutional neural networks to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The lip to carina length predicted by AI model
Time Frame: 1 minute after DCNNs analysis
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The mean absolute error of AI-predicted length in comparison with measured length is used to evaluate AI performance
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1 minute after DCNNs analysis
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of endotracheal tube malpositioning according to AI model recommendation
Time Frame: 1 minute after DCNNs analysis
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Endotracheal tube malpositioning is used to elevate the safty of AI recommendation.
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1 minute after DCNNs analysis
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lakhani P. Deep Convolutional Neural Networks for Endotracheal Tube Position and X-ray Image Classification: Challenges and Opportunities. J Digit Imaging. 2017 Aug;30(4):460-468. doi: 10.1007/s10278-017-9980-7.
- Lakhani P, Flanders A, Gorniak R. Endotracheal Tube Position Assessment on Chest Radiographs Using Deep Learning. Radiol Artif Intell. 2020 Nov 18;3(1):e200026. doi: 10.1148/ryai.2020200026. eCollection 2021 Jan.
- Eagle CC. The relationship between a person's height and appropriate endotracheal tube length. Anaesth Intensive Care. 1992 May;20(2):156-60. doi: 10.1177/0310057X9202000206.
- Varshney M, Sharma K, Kumar R, Varshney PG. Appropriate depth of placement of oral endotracheal tube and its possible determinants in Indian adult patients. Indian J Anaesth. 2011 Sep;55(5):488-93. doi: 10.4103/0019-5049.89880.
- Techanivate A, Rodanant O, Charoenraj P, Kumwilaisak K. Depth of endotracheal tubes in Thai adult patients. J Med Assoc Thai. 2005 Jun;88(6):775-81.
- Herway ST, Benumof JL. The tracheal accordion and the position of the endotracheal tube. Anaesth Intensive Care. 2017 Mar;45(2):177-188. doi: 10.1177/0310057X1704500207.
- Chong DY, Greenland KB, Tan ST, Irwin MG, Hung CT. The clinical implication of the vocal cords-carina distance in anaesthetized Chinese adults during orotracheal intubation. Br J Anaesth. 2006 Oct;97(4):489-95. doi: 10.1093/bja/ael186. Epub 2006 Jul 27.
- Conrardy PA, Goodman LR, Lainge F, Singer MM. Alteration of endotracheal tube position. Flexion and extension of the neck. Crit Care Med. 1976 Jan-Feb;4(1):8-12. doi: 10.1097/00003246-197601000-00002. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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