Artificial Intelligence (AI)NCT06770985
Effectiveness of Artificial Intelligence Algorithms
An observational study of Artificial Intelligence (AI), run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Introduction Throughout human history, surgical interventions have been frequently used in human treatment. However, despite their therapeutic properties, the pain experienced by patients, especially in the acute postoperative period, can be quite challenging for clinicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence (AI)
- What is being tested?
- Artificial Intelligence
- How many people
- 601 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2025to 20 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent lung resection surgery between January 2023 and October 2024 and have a complete pain follow-up form will be included in our retro-prospective cross-sectional study.
Who may be able to join
- Age > 18,
- Patients who underwent lung resection between January 2023 and October 2024 will be included.
Who cannot join
- Patients under 18 years of age
- Patients with missing postoperative pain form
- Patients who did not undergo lung resection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
About this study
Official title: Effectiveness of Artificial Intelligence Algorithms in Predicting Postoperative Pain in Lung Resections
Introduction Throughout human history, surgical interventions have been frequently used in human treatment. However, despite their therapeutic properties, the pain experienced by patients, especially in the acute postoperative period, can be quite challenging for clinicians. Acute postoperative pain is an important public health issue. While 80% of patients report experiencing pain in the postoperative period, 88% of them experience moderate or higher levels of pain. According to another study, more than 60% of surgical patients suffer from moderate to severe acute postoperative pain, and this pain has been associated with the development of chronic postoperative pain. Poorly managed postoperative pain can lead to negative outcomes such as lower patient satisfaction, delayed patient recovery, increased length of hospital stay, increased care costs, chronic pain, unnecessary opioid prescription, opioid abuse, overdose, and death. In addition, in order to provide effective pain management, the method of providing preventive analgesic treatment before the pain begins is frequently used. However, this situation may lead to unnecessary medication administration in many patients and consequently, many adverse events such as bleeding, respiratory depression, cardiac events or gastrointestinal system side effects of opioids, nonsteroidal anti-inflammatory drugs and other analgesics. As a result, the difficulty in predicting acute postoperative pain leads to suboptimal pain management. Therefore, being able to predict which patients will suffer from moderate to severe acute postoperative pain will optimize the risk-benefit ratio of perioperative analgesic treatments and ensure that appropriate treatment is given. Although different studies on this subject have tried to predict postoperative pain with logistic regression analysis, the desired result has not yet been achieved. This situation becomes even more important in surgeries with a high risk of severe pain in the postoperative period, such as lung resection. In order to reduce or prevent postoperative pulmonary complications in patients undergoing lung resection, it is very important for patients to be able to cough without feeling pain and thus to remove secretions from the respiratory tract. If sufficient analgesia is not provided, these patients cannot perform this effectively. This increases complications, hospital stay, and patient care costs. In order to prevent these negative situations and provide optimal analgesia, new methods are needed to predict postoperative pain levels. Numerous models have been proposed in studies to understand the risk factors that will exacerbate severe acute postoperative pain. Most of the research in this area has focused on determining risk factors for postoperative pain using statistical methodology. Previous studies suggest that machine learning models can outperform linear statistical models in classifying postoperative pain-related outcomes when similar features are considered. Therefore, artificial intelligence (AI) algorithms are algorithms that can combine and analyze complex data with hundreds of variables and provide new outputs, and can guide an effective solution in predicting and managing the postoperative process. Previous studies have shown promising results in predicting acute postoperative pain with an area under the curve (AUC) of 0.70 using artificial intelligence algorithms to predict pain with perioperative data. However, studies on this topic are needed in a specific surgery such as lung resection, which has the potential for severe pain.
This study aimed to predict postoperative pain by analyzing perioperative data using AI algorithms in lung resections and to determine the effectiveness of AI algorithms in this regard. Thus, it aimed to reduce unnecessary analgesic use in patients, eliminate possible side effects of these drugs, and start effective analgesic treatment in a timely manner in patients with high pain risk.
Read more
Purpose/Hypothesis:
This study aimed to predict postoperative pain by analyzing perioperative data using AI algorithms in lung resections and to determine the effectiveness of AI algorithms in this regard.
H0: Artificial intelligence algorithms are not effective in predicting postoperative pain in lung resections.
H1: Artificial intelligence algorithms are effective in predicting postoperative pain in lung resections.
Material-Method:
This study will be conducted in accordance with the Declaration of Helsinki and will be carried out at the SBÜ Ankara Atatürk Sanatorium Training and Research Hospital after receiving ethics committee approval. Our study is a retro-prospective study. Retrospectively collected patient data will be evaluated prospectively with artificial intelligence algorithms.
- Conditions
- Artificial Intelligence (AI)
- Being tested
- Artificial Intelligence
- Keywords
- artificial intelligence, postoperative pain, lung resections
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial IntelligenceOther
Also called AI
Ollama (Ollama., 2024, https://ollama.ai/) artificial intelligence program and "PYTHON 3 Programming Language" and open source libraries will be used for the necessary algorithms for data review and analysis. In case of deficiencies in the data of the patients; the missing data will be edited using "Data Imputation" techniques. Number of files to be reviewed and/or date range to be covered: Patients who underwent lung resection between January 2023 and October 2024 will be included. An estimated 2000 files are planned to be scanned.
| Study group | Role | What they receive |
|---|---|---|
| Lung Resection | patients who underwent lung resection between January 2023 and October 2024 Receives: Other: Artificial Intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
NRS is the verbal or written determination of the pain level on a scale between 0 and 10; where 0 represents no pain and 10 represents unbearable pain. NRS 1-3; mild pain, NRS 4-6; moderate pain, NRS 7-10; severe pain will be defined.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start8 Jan 2025
- Primary completion15 Jul 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Baldemir, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770985
- Sponsor's protocol ID
- 2024-BÇEK/177
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Artificial Intelligence Algorithms in Predicting Postoperative Pain in Lung Resections
- ClinicalTrials.gov ID
- NCT06770985
- Acronym / sponsor ID
- 2024-BÇEK/177
- Conditions
- Artificial Intelligence (AI)
- Keywords
- artificial intelligence, postoperative pain, lung resections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 13 Jan 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.
Introduction Throughout human history, surgical interventions have been frequently used in human treatment. However, despite their therapeutic properties, the pain experienced by patients, especially in the acute postoperative period, can be quite challenging for clinicians. Acute postoperative pain is an important public health issue. While 80% of patients report experiencing pain in the postoperative period, 88% of them experience moderate or higher levels of pain. According to another study, more than 60% of surgical patients suffer from moderate to severe acute postoperative pain, and this pain has been associated with the development of chronic postoperative pain. Poorly managed postoperative pain can lead to negative outcomes such as lower patient satisfaction, delayed patient recovery, increased length of hospital stay, increased care costs, chronic pain, unnecessary opioid prescription, opioid abuse, overdose, and death. In addition, in order to provide effective pain management, the method of providing preventive analgesic treatment before the pain begins is frequently used. However, this situation may lead to unnecessary medication administration in many patients and consequently, many adverse events such as bleeding, respiratory depression, cardiac events or gastrointestinal system side effects of opioids, nonsteroidal anti-inflammatory drugs and other analgesics. As a result, the difficulty in predicting acute postoperative pain leads to suboptimal pain management. Therefore, being able to predict which patients will suffer from moderate to severe acute postoperative pain will optimize the risk-benefit ratio of perioperative analgesic treatments and ensure that appropriate treatment is given. Although different studies on this subject have tried to predict postoperative pain with logistic regression analysis, the desired result has not yet been achieved. This situation becomes even more important in surgeries with a high risk of severe pain in the postoperative period, such as lung resection. In order to reduce or prevent postoperative pulmonary complications in patients undergoing lung resection, it is very important for patients to be able to cough without feeling pain and thus to remove secretions from the respiratory tract. If sufficient analgesia is not provided, these patients cannot perform this effectively. This increases complications, hospital stay, and patient care costs. In order to prevent these negative situations and provide optimal analgesia, new methods are needed to predict postoperative pain levels. Numerous models have been proposed in studies to understand the risk factors that will exacerbate severe acute postoperative pain. Most of the research in this area has focused on determining risk factors for postoperative pain using statistical methodology. Previous studies suggest that machine learning models can outperform linear statistical models in classifying postoperative pain-related outcomes when similar features are considered. Therefore, artificial intelligence (AI) algorithms are algorithms that can combine and analyze complex data with hundreds of variables and provide new outputs, and can guide an effective solution in predicting and managing the postoperative process. Previous studies have shown promising results in predicting acute postoperative pain with an area under the curve (AUC) of 0.70 using artificial intelligence algorithms to predict pain with perioperative data. However, studies on this topic are needed in a specific surgery such as lung resection, which has the potential for severe pain.
This study aimed to predict postoperative pain by analyzing perioperative data using AI algorithms in lung resections and to determine the effectiveness of AI algorithms in this regard. Thus, it aimed to reduce unnecessary analgesic use in patients, eliminate possible side effects of these drugs, and start effective analgesic treatment in a timely manner in patients with high pain risk.
Purpose/Hypothesis:
This study aimed to predict postoperative pain by analyzing perioperative data using AI algorithms in lung resections and to determine the effectiveness of AI algorithms in this regard.
H0: Artificial intelligence algorithms are not effective in predicting postoperative pain in lung resections.
H1: Artificial intelligence algorithms are effective in predicting postoperative pain in lung resections.
Material-Method:
This study will be conducted in accordance with the Declaration of Helsinki and will be carried out at the SBÜ Ankara Atatürk Sanatorium Training and Research Hospital after receiving ethics committee approval. Our study is a retro-prospective study. Retrospectively collected patient data will be evaluated prospectively with artificial intelligence algorithms.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Resection | – | Other: Artificial Intelligencepatients who underwent lung resection between January 2023 and October 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent lung resection surgery between January 2023 and October 2024 and have a complete pain follow-up form will be included in our retro-prospective cross-sectional study.
Key inclusion criteria (2 listed)
- Age > 18,
- Patients who underwent lung resection between January 2023 and October 2024 will be included.
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Patients with missing postoperative pain form
- Patients who did not undergo lung resection
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 |
|---|---|---|
| Artificial IntelligenceAlso: AIOllama (Ollama., 2024, https://ollama.ai/) artificial intelligence program and "PYTHON 3 Programming Language" and open source libraries will be used for the necessary algorithms for data review and analysis. In case of deficiencies in the data of the patients; the missing data will be edited using "Data Imputation" techniques. Number of files to be reviewed and/or date range to be covered: Patients who underwent lung resection between January 2023 and October 2024 will be included. An estimated 2000 files are planned to be scanned. | Other | Lung Resection |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: 24 hour
NRS is the verbal or written determination of the pain level on a scale between 0 and 10; where 0 represents no pain and 10 represents unbearable pain. NRS 1-3; mild pain, NRS 4-6; moderate pain, NRS 7-10; severe pain will be defined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Artificial Intelligence (AI), run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 22 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: 24 hour). 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 22 Jan 2026.