Critical Care MedicineETPAAS-1NCT06857019
Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System"
A study testing "Endotracheal Tube Position Anomaly Alerting System" in people with Critical Care Medicine and Mechanical Ventilation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to determine whether the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) effectively reduces the duration of endotracheal tube malposition in patients admitted to the intensive care unit (ICU). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Care Medicine, Mechanical Ventilation, Radiographic Image Interpretation, Computer-Assisted
- What is being tested?
- "Endotracheal Tube Position Anomaly Alerting System"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the intensive care unit
- At least 18 years old
Who cannot join
- Patients disagree to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Ming-Ju Tsai, M.D., Ph.D., +88673121101 ext. 5901, SiegfriedTsai@gmail.com
Ming-Ju Tsai, M.D., Ph.D.
About this study
The goal of this clinical trial is to determine whether the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) effectively reduces the duration of endotracheal tube malposition in patients admitted to the intensive care unit (ICU). Additionally, the study will assess the clinical impact, usability, and user satisfaction of ETPAAS.
The main questions it aims to answer are:
Read more
- Does ETPAAS reduce the duration of endotracheal tube malposition?
- What are healthcare workers' perspectives on the usability and satisfaction of ETPAAS?
Participants will receive standard care, with or without ETPAAS, in the intensive care unit.
Researchers will evaluate the duration of endotracheal tube malposition. Healthcare workers will complete a questionnaire assessing the usability and satisfaction of ETPAAS.
- Conditions
- Critical Care Medicine, Mechanical Ventilation, Radiographic Image Interpretation, Computer-Assisted, Alarms
- Being tested
- "Endotracheal Tube Position Anomaly Alerting System"
- Keywords
- Chest X-ray, Chest radiograph, Endotracheal tube, Intubation, Intratracheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Endotracheal Tube Position Anomaly Alerting System"Other
Also called ETPAAS
The "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS) is designed to assist healthcare providers in managing patients receiving mechanical ventilation via an endotracheal tube. This system integrates an artificial intelligence (AI) algorithm that automatically evaluates the appropriateness of endotracheal tube positioning whenever a patient's chest X-ray is uploaded. If the system detects that the distance between the endotracheal tube tip and the carina falls outside the optimal range, it promptly alerts healthcare providers, enabling timely intervention to correct the tube position and enhance patient safety.
| Study group | Role | What they receive |
|---|---|---|
| ETPAAS | Experimental | Participants receive standard of care, with "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS), in the intensive care unit. Receives: Other: "Endotracheal Tube Position Anomaly Alerting System" |
| Control | No intervention | Participants receive standard of care, without ETPAAS, in the intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of endotracheal tube malposition
Measured: from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours
Secondary outcomes (10)
Usability and user satisfaction survey with a questionnaire
Measured: through study completion, up to 6 months
Prevalence of endotracheal tube malposition
Prevalence of endotracheal tube malposition on the first chest radiograph on ICU admission and on the second chest radiograph taken in the ICU
Measured: through study completion, up to 6 months
ICU length of stay
Measured: from ICU admission to ICU discharge, an estimated average of 7 days
Duration of mechanical ventilation
Measured: from intubation to the discontinuation of mechanical ventilation, an estimated average of 5 days
Weaning rate of mechanical ventilation
Measured: from intubation to the successful discontinuation of mechanical ventilation, assessed up to 5 months
Accuracy of the ETPAAS
The accuracy of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be evaluated by comparing its automated assessments of endotracheal tube (ETT) positioning with expert clinical interpretations. Accuracy will be determined based on the system's sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in detecting ETT malposition. The reference standard will be assessments made by experienced intensivists.
Measured: through study completion, up to 6 months
Precision of the ETPAAS
The precision of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be evaluated by assessing the consistency and reliability of its automated endotracheal tube (ETT) position anomaly detection. Precision will be measured as the proportion of correctly identified malpositioned ETT cases among all positive alerts generated by the system (i.e., positive predictive value, PPV).
Measured: through study completion, up to 6 months
Recall of the ETPAAS
The recall of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be assessed by evaluating its ability to correctly identify cases of endotracheal tube (ETT) malposition. Recall will be quantified as the proportion of true positive cases detected by ETPAAS among all actual cases of ETT malposition, also known as sensitivity. A higher recall value indicates the system's effectiveness in minimizing missed detections and ensuring timely alerts for clinical intervention.
Measured: through study completion, up to 6 months
F1 score of the ETPAAS
The F1 score of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be used to assess the balance between precision and recall in detecting endotracheal tube (ETT) malposition. The F1 score is the harmonic mean of precision and recall. A higher F1 score indicates that ETPAAS effectively identifies ETT malposition with both high accuracy and low false-negative and false-positive rates. This metric provides a comprehensive evaluation of the system's performance in a clinical setting.
Measured: through study completion, up to 6 months
Area under the curve (AUC) of receiver operating characteristic (ROC) curve of the ETPAAS
The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve will be used to evaluate the overall diagnostic performance of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) in detecting endotracheal tube (ETT) malposition. The ROC curve plots the true positive rate (sensitivity) against the false positive rate (1 - specificity) at various classification thresholds. The AUC value ranges from 0 to 1, where:
- AUC = 1.0 indicates perfect classification performance.
- AUC = 0.5 suggests no better performance than random chance.
- Higher AUC values indicate superior discriminatory ability of ETPAAS in correctly distinguishing between correctly positioned and malpositioned ETT cases.
This metric provides a robust measure of the system's reliability and effectiveness in clinical decision support.
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start24 Feb 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care MedicineStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Ju Tsai, M.D., Ph.D., Study director, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857019
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240327
- Acronym
- ETPAAS-1
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be made available to qualified researchers with academic interests in related fields. All shared data will be coded and stripped of any protected health information. Data sharing will be contingent upon the approval of the request and the execution of all applicable agreements (e.g., a material transfer agreement) before access is granted to the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System"
- ClinicalTrials.gov ID
- NCT06857019
- Acronym / sponsor ID
- ETPAAS-1 / KMUHIRB-F(I)-20240327
- Conditions
- Critical Care Medicine, Mechanical Ventilation, Radiographic Image Interpretation, Computer-Assisted, Alarms
- Keywords
- Chest X-ray, Chest radiograph, Endotracheal tube, Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) effectively reduces the duration of endotracheal tube malposition in patients admitted to the intensive care unit (ICU). Additionally, the study will assess the clinical impact, usability, and user satisfaction of ETPAAS.
The main questions it aims to answer are:
- Does ETPAAS reduce the duration of endotracheal tube malposition?
- What are healthcare workers' perspectives on the usability and satisfaction of ETPAAS?
Participants will receive standard care, with or without ETPAAS, in the intensive care unit.
Researchers will evaluate the duration of endotracheal tube malposition. Healthcare workers will complete a questionnaire assessing the usability and satisfaction of ETPAAS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETPAAS | Experimental | Other: "Endotracheal Tube Position Anomaly Alerting System"Participants receive standard of care, with "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS), in the intensive care unit. |
| Control | No intervention | –Participants receive standard of care, without ETPAAS, in the intensive care unit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the intensive care unit
- At least 18 years old
Key exclusion criteria (1 listed)
- Patients disagree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Endotracheal Tube Position Anomaly Alerting System"Also: ETPAASThe "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS) is designed to assist healthcare providers in managing patients receiving mechanical ventilation via an endotracheal tube. This system integrates an artificial intelligence (AI) algorithm that automatically evaluates the appropriateness of endotracheal tube positioning whenever a patient's chest X-ray is uploaded. If the system detects that the distance between the endotracheal tube tip and the carina falls outside the optimal range, it promptly alerts healthcare providers, enabling timely intervention to correct the tube position and enhance patient safety. | Other | ETPAAS |
Primary outcome
Duration of endotracheal tube malposition
Time frame: from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours
10 secondary outcomes
Usability and user satisfaction survey with a questionnaire
Time frame: through study completion, up to 6 months
Prevalence of endotracheal tube malposition
Time frame: through study completion, up to 6 months
ICU length of stay
Time frame: from ICU admission to ICU discharge, an estimated average of 7 days
Duration of mechanical ventilation
Time frame: from intubation to the discontinuation of mechanical ventilation, an estimated average of 5 days
Weaning rate of mechanical ventilation
Time frame: from intubation to the successful discontinuation of mechanical ventilation, assessed up to 5 months
Accuracy of the ETPAAS
Time frame: through study completion, up to 6 months
Precision of the ETPAAS
Time frame: through study completion, up to 6 months
Recall of the ETPAAS
Time frame: through study completion, up to 6 months
F1 score of the ETPAAS
Time frame: through study completion, up to 6 months
Area under the curve (AUC) of receiver operating characteristic (ROC) curve of the ETPAAS
Time frame: through study completion, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be made available to qualified researchers with academic interests in related fields. All shared data will be coded and stripped of any protected health information. Data sharing will be contingent upon the approval of the request and the execution of all applicable agreements (e.g., a material transfer agreement) before access is granted to the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-Ju Tsai, M.D., Ph.D. study director
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Endotracheal Tube Position Anomaly Alerting System" in people with Critical Care Medicine and Mechanical Ventilation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Ju Tsai, M.D., Ph.D. (+88673121101 ext. 5901, SiegfriedTsai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of endotracheal tube malposition (time frame: from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.