NCT05085743

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
595

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

September 24, 2021

Last Update Submit

October 6, 2021

Conditions

Keywords

Depth of ETT fixationDeep convolutional neural networksChest radiographs

Outcome Measures

Primary Outcomes (1)

  • The lip to carina length predicted by AI model

    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 Outcomes (1)

  • Rate of endotracheal tube malpositioning according to AI model recommendation

    1 minute after DCNNs analysis

Study Arms (2)

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.

Diagnostic Test: Deep convolutional neural networks analysis

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.

Diagnostic Test: Deep convolutional neural networks analysis

Interventions

using Deep convolutional neural networks to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation

TrainingValidation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Linkou branch

Taoyuan District, Guishan Township, 333, Taiwan

Location

Related Publications (8)

  • 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.

    PMID: 28600640BACKGROUND
  • 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.

    PMID: 33937852BACKGROUND
  • 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.

    PMID: 1595848BACKGROUND
  • 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.

    PMID: 22174466BACKGROUND
  • 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.

    PMID: 16083218BACKGROUND
  • 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.

    PMID: 28267939BACKGROUND
  • 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.

    PMID: 16873383BACKGROUND
  • 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.

    PMID: 1253616BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 20, 2021

Study Start

November 1, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations