Clinical Decision Support SystemNCT06270797
Pre-anesthesia Imaging-based Respiratory Assessment and Analysis
An observational study of Clinical Decision Support System, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Decision Support System
- What is being tested?
- intubation for general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 30,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 31 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing regular general anesthesia with pre-anesthetic consultation and airway examination.
Who may be able to join
- Patients undergoing general anesthesia
- Patients who can undergo pre-anesthetic consultation and airway examination.
Who cannot join
- Patients unable to undergo pre-anesthetic consultation and airway examination.
- Patients requiring emergency surgery.
- Vulnerable populations.
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, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 80756
Tz Ping Gau, MD, +886912060962, u9401066@gap.kmu.edu.tw
About this study
This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system.
Read the detailed description
Anesthesia respiratory assessment is an important issue for anesthesiologists to evaluate the respiratory status and airway management of patients before surgery. The American Society of Anesthesiologists (ASA) updated its guidelines in 2022, emphasizing the importance of comprehensive respiratory assessment in the guidelines.
Various risk factors have been proposed in past literature for discussion, and corresponding to these risk factors, there is currently no single factor that can predict difficult intubation completely. Existing investigations into difficult intubation factors mostly focus on high-risk populations, including patients with morbid obesity, where significant differences have been identified but not developed into predictive models.
With the rapid development of AI-related technologies in recent years, numerous image-related AI frameworks have been proposed. In recent years, attempts have been made to combine various clinical risk factors using machine learning methods to create automated prediction models for difficult intubation. However, their effectiveness has not met expectations, reflecting the significant clinical problem of difficulty in prediction that remains unresolved.
This study is an observational study aimed at analyzing and establishing patient image data, refining various data engineering techniques, and optimizing existing prediction model frameworks to enhance their medical value. Additionally, the focus of this project will be on establishing more prediction models to improve existing clinical decision support systems.
- Conditions
- Clinical Decision Support System
- Being tested
- intubation for general anesthesia
- Keywords
- knowledge graph, artificial intelligence, Enhanced Recovery After Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation for general anesthesiaProcedure or surgery
routine intubation for general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| normal intubation | during general anesthesia, normal intubation without any difficult airway or difficult intubation were recorded in the note. Receives: Procedure: intubation for general anesthesia | |
| difficult airway or difficult intubation | during general anesthesia, any type of difficult airway or difficult intubation were recorded in the note. Receives: Procedure: intubation for general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
A pre-anesthesia evaluation
The examination includes airway assessment and dental evaluation.
Measured: pre-anesthetic consultation about 20 min
Perform non-invasive imaging capture.
The capture involves non-invasive imaging of the patient's facial features through standard basic photography, excluding any additional radiographic imaging examinations.The patient's images will be stored in de-identified form.
Measured: pre-anesthetic consultation about 5 min
difficult intubation prediction
The prediction of difficult intubation from pre-anesthesia evaluation and non-invasive imaging capture
Measured: after pre-anesthetic consultation about 5 min
Secondary outcomes (3)
time to successfully extubate the nasotracheal tube after anesthesia
early extubation allowable
Measured: from the end of surgery to the post-anesthesia care, assessed up to one hour
safely discharged from post-anesthesia care unit (postoperative recovery room)
as calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.
Measured: 2 hours
side effects and adverse events
records any abnormal surgical or anesthesia related findings during this admission
Measured: intraoperative and postoperative stages, assessed up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision Support SystemStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-I Cheng, MD,Phd, Study director, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270797
- Sponsor's protocol ID
- KMUHIRB-E(I)-20230184
- Status last verified
- Dec 2023
- First submitted
- 14 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-anesthesia Imaging-based Respiratory Assessment and Analysis
- ClinicalTrials.gov ID
- NCT06270797
- Acronym / sponsor ID
- KMUHIRB-E(I)-20230184
- Conditions
- Clinical Decision Support System
- Keywords
- knowledge graph, artificial intelligence, Enhanced Recovery After Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2024 (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.
This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system.
Detailed description
Anesthesia respiratory assessment is an important issue for anesthesiologists to evaluate the respiratory status and airway management of patients before surgery. The American Society of Anesthesiologists (ASA) updated its guidelines in 2022, emphasizing the importance of comprehensive respiratory assessment in the guidelines.
Various risk factors have been proposed in past literature for discussion, and corresponding to these risk factors, there is currently no single factor that can predict difficult intubation completely. Existing investigations into difficult intubation factors mostly focus on high-risk populations, including patients with morbid obesity, where significant differences have been identified but not developed into predictive models.
With the rapid development of AI-related technologies in recent years, numerous image-related AI frameworks have been proposed. In recent years, attempts have been made to combine various clinical risk factors using machine learning methods to create automated prediction models for difficult intubation. However, their effectiveness has not met expectations, reflecting the significant clinical problem of difficulty in prediction that remains unresolved.
This study is an observational study aimed at analyzing and establishing patient image data, refining various data engineering techniques, and optimizing existing prediction model frameworks to enhance their medical value. Additionally, the focus of this project will be on establishing more prediction models to improve existing clinical decision support systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal intubation | – | Procedure: intubation for general anesthesiaduring general anesthesia, normal intubation without any difficult airway or difficult intubation were recorded in the note. |
| difficult airway or difficult intubation | – | Procedure: intubation for general anesthesiaduring general anesthesia, any type of difficult airway or difficult intubation were recorded in the note. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing regular general anesthesia with pre-anesthetic consultation and airway examination.
Key inclusion criteria (2 listed)
- Patients undergoing general anesthesia
- Patients who can undergo pre-anesthetic consultation and airway examination.
Key exclusion criteria (3 listed)
- Patients unable to undergo pre-anesthetic consultation and airway examination.
- Patients requiring emergency surgery.
- Vulnerable populations.
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 |
|---|---|---|
| intubation for general anesthesiaroutine intubation for general anesthesia | Procedure or surgery | difficult airway or difficult intubation, normal intubation |
Primary outcome
A pre-anesthesia evaluation
Time frame: pre-anesthetic consultation about 20 min
The examination includes airway assessment and dental evaluation.
Perform non-invasive imaging capture.
Time frame: pre-anesthetic consultation about 5 min
The capture involves non-invasive imaging of the patient's facial features through standard basic photography, excluding any additional radiographic imaging examinations.The patient's images will be stored in de-identified form.
difficult intubation prediction
Time frame: after pre-anesthetic consultation about 5 min
The prediction of difficult intubation from pre-anesthesia evaluation and non-invasive imaging capture
3 secondary outcomes
time to successfully extubate the nasotracheal tube after anesthesia
Time frame: from the end of surgery to the post-anesthesia care, assessed up to one hour
safely discharged from post-anesthesia care unit (postoperative recovery room)
Time frame: 2 hours
side effects and adverse events
Time frame: intraoperative and postoperative stages, assessed up to 48 hours
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 21 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Kuang-I Cheng, MD,Phd study director
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Decision Support System, 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 3 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: looking for participants now, as of the sponsor's last update on 21 Feb 2024. 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 Tz Ping Gau, MD (+886912060962, u9401066@gap.kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A pre-anesthesia evaluation (time frame: pre-anesthetic consultation about 20 min). The study lists 3 primary outcomes in all. 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 21 Feb 2024.