Coronary Artery DiseaseNCT07581678
Five Multimodal AI Configurations Versus Expert Anaesthesiologists for Classifying Pecto-Intercostal Fascial Plane Block Spread in CABG
An observational study of Coronary Artery Disease and Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort with a nested archived-image reader study compared the sonographic pecto-intercostal fascial plane block classifications of five general-purpose multimodal artificial-intelligence configurations and three expert anaesthesiologists against a separate senior anaesthesiologist's… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Postoperative Pain
- What is being tested?
- Pecto-Intercostal Fascial Plane Block
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing elective isolated coronary artery bypass grafting through median sternotomy. On days when the consultant anaesthesiologist responsible for pecto-intercostal fascial plane block and ultrasound acquisition was available, every eligible patient was invited consecutively.
Who may be able to join
- Age 18-80 years
- American Society of Anesthesiologists physical status III
- Scheduled for elective isolated coronary artery bypass grafting through median sternotomy
- Written informed consent for study participation and research/AI assessment of de-identified ultrasound images
Who cannot join
- Emergency surgery
- Redo sternotomy
- Minimally invasive or thoracotomy surgical approach
- Allergy to local anaesthetics
- International normalised ratio greater than 1.5 or platelet count below 80,000 per microlitre
- Infection at the planned injection site
Show all 9Show fewer
- Chronic opioid use for more than 3 months
- Cognitive dysfunction
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Yıldırım, Bursa, 16310
About this study
Official title: AI-Assisted Evaluation of Anatomical Success of Fascial Plane Blocks Applied in Open Heart Surgery and Investigation of Its Relationship With Postoperative Pain Scores: A Prospective Observational Study
This prospective observational cohort with a nested archived-image reader study compared the sonographic pecto-intercostal fascial plane block classifications of five general-purpose multimodal artificial-intelligence configurations and three expert anaesthesiologists against a separate senior anaesthesiologist's single-expert reference. Adults undergoing elective isolated coronary artery bypass grafting through median sternotomy were enrolled consecutively on days when the consultant anaesthesiologist responsible for block performance and ultrasound acquisition was available. Standardised left-sided ultrasound videos were recorded in 120 consented participants. Bilateral pecto-intercostal fascial plane block was performed in 115 participants; five participants who declined the block consented to standardised ultrasound imaging and served as no-block image controls. Eight to ten representative de-identified frames from each video were assessed independently by all readers. Associations between reference-defined sonographic spread and postoperative pain were secondary and observational.
Read the detailed description
This single-centre prospective observational cohort included 120 consenting adults undergoing elective isolated coronary artery bypass grafting through median sternotomy. At the end of surgery, after complete sternal and skin closure, 115 participants received bilateral ultrasound-guided pecto-intercostal fascial plane block with 20 mL of 0.25% bupivacaine on each side (40 mL and 100 mg in total). Five participants declined the block but consented to Ethics Committee-authorised standardised ultrasound imaging, storage and subsequent de-identified human/AI assessment; no needle was inserted and no local anaesthetic was administered in this group.
Ultrasound videos were acquired from the left side with an M5 portable ultrasound system and a 7L4s linear-array transducer at a nominal frequency of 7.5 MHz using standardised settings. Eight to ten representative frames were selected from each video across the pre-block view, needle advancement, local-anaesthetic spread and final post-injection view, as applicable. The same frame set and fixed participant order were shown to every reader.
After participant follow-up had ended, five general-purpose multimodal AI configurations, three expert anaesthesiologists and one separate senior reference anaesthesiologist independently classified each image set as successful, patchy/inadequate or failed/no local anaesthetic. The evaluated configurations were Gemini 3.5 Flash, Claude Sonnet 4.6, GPT-5.5 Instant in ChatGPT, Grok 4.3 and Kimi K2.6. They were accessed through free, non-subscription consumer accounts using their standard web interfaces and default response and data-use settings. For each system-participant pair, a new conversation was opened, the same fixed prompt and image set were submitted, and the first response was recorded without regeneration or re-prompting. The visible conversation was deleted before the next assessment, although this did not establish provider-side deletion. Each configuration assessed each participant once; within-system repeatability was not evaluated. The number and identities of the five consumer configurations were fixed before any reader output was observed; no bespoke AI model was developed or trained. The separate senior anaesthesiologist was a pragmatic single-expert reference and not an objective gold standard. The study was not designed as an equivalence or non-inferiority analysis.
Postoperative Numerical Rating Scale pain at rest and during coughing was scheduled at 6, 12, 24 and 48 hours. The 6-hour assessment was applicable only to participants who had already been extubated at that time. Rescue analgesic administration during the first 48 hours, intensive-care and hospital length of stay, complications and mortality were also recorded. Pain associations were secondary, observational and non-causal.
The ClinicalTrials.gov record was first submitted on 6 May 2026 and first posted on 12 May 2026, after the study had begun but while recruitment, image acquisition and clinical follow-up were still ongoing. Registration was therefore retrospective relative to study start. Image acquisition ended on 27 May 2026 and participant clinical follow-up ended on 1 June 2026.
- Conditions
- Coronary Artery Disease, Postoperative Pain
- Being tested
- Pecto-Intercostal Fascial Plane Block
- Keywords
- artificial intelligence, multimodal AI, ultrasonography, regional anaesthesia, pecto-intercostal fascial plane block, coronary artery bypass grafting, postoperative pain, reader study
- Medical subject headings
- Coronary Artery Disease, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecto-Intercostal Fascial Plane BlockProcedure or surgery
Bilateral ultrasound-guided PIFB performed after complete sternal and skin closure as routine clinical care, using 20 mL of 0.25% bupivacaine on each side (40 mL; 100 mg total).
| Study group | Role | What they receive |
|---|---|---|
| PIFB-Treated Cohort | One hundred fifteen consenting adults undergoing elective isolated coronary artery bypass grafting received bilateral ultrasound-guided pecto-intercostal fascial plane block at the end of surgery. Their archived ultrasound image sets were included in the principal reader-performance and secondary clinical analyses. Receives: Procedure: Pecto-Intercostal Fascial Plane Block | |
| Consented No-Block Image Controls | Five participants declined pecto-intercostal fascial plane block and consented to Ethics Committee-authorised standardised ultrasound imaging and research/AI assessment. No needle was inserted and no local anaesthetic was administered. Their image sets were included in the same reader series as the treated cohort. They were excluded from treated-cohort binary reader-performance and pain analyses. These participants were no-block image controls, not attempted-block failures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balanced Accuracy of Binary PIFB Classification Against a Single-Expert Reference
Among 115 participants who received pecto-intercostal fascial plane block, binary classifications from each of five general-purpose multimodal artificial-intelligence configurations and three expert anaesthesiologists were compared separately with the classification of a senior anaesthesiologist serving as a pragmatic single-expert reference. Successful was the positive category; patchy/inadequate and failed/no local anaesthetic were combined as not successful. Balanced accuracy was calculated as (sensitivity + specificity)/2 and reported from 0 to 1, with higher values indicating closer agreement with the reference. The reference was not an objective gold standard, and no equivalence or non-inferiority hypothesis was tested.
Measured: June 2026; each archived image set was assessed once by each reader.
Secondary outcomes (16)
Sensitivity of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Sensitivity was the percentage of image sets classified as successful by a reader among image sets classified as successful by the pragmatic single-expert reference. It was calculated separately for each of the five artificial-intelligence configurations and three expert anaesthesiologists in the 115 PIFB-treated participants. Possible values range from 0 to 100 percent; higher values indicate closer agreement with the reference.
Measured: June 2026; each archived image set was assessed once by each reader.
Specificity of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Specificity was the percentage of image sets classified as not successful by a reader among image sets classified as not successful by the pragmatic single-expert reference. Patchy/inadequate and failed/no local anaesthetic were grouped as not successful. It was calculated separately for each of the five artificial-intelligence configurations and three expert anaesthesiologists in the 115 PIFB-treated participants. Possible values range from 0 to 100 percent; higher values indicate closer agreement with the reference.
Measured: June 2026; each archived image set was assessed once by each reader.
Positive Predictive Value of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Positive predictive value was the percentage of image sets classified as successful by a reader that were also classified as successful by the pragmatic single-expert reference. It was calculated separately for each of the five artificial-intelligence configurations and three expert anaesthesiologists in the 115 PIFB-treated participants. Possible values range from 0 to 100 percent; higher values indicate closer agreement with the reference.
Measured: June 2026; each archived image set was assessed once by each reader.
Negative Predictive Value of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Negative predictive value was the percentage of image sets classified as not successful by a reader that were also classified as not successful by the pragmatic single-expert reference. Patchy/inadequate and failed/no local anaesthetic were grouped as not successful. It was calculated separately for each of the five artificial-intelligence configurations and three expert anaesthesiologists in the 115 PIFB-treated participants. Possible values range from 0 to 100 percent; higher values indicate closer agreement with the reference.
Measured: June 2026; each archived image set was assessed once by each reader.
Overall Accuracy of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Overall accuracy was the percentage of the 115 PIFB-treated image sets for which a reader's binary successful or not-successful classification matched the pragmatic single-expert reference. It was calculated separately for each of the five artificial-intelligence configurations and three expert anaesthesiologists. Possible values range from 0 to 100 percent; higher values indicate closer agreement with the reference.
Measured: June 2026; each archived image set was assessed once by each reader.
Linear-Weighted Cohen Kappa for Three-Category Agreement With the Single-Expert Reference
Across all 120 image sets, linear-weighted Cohen kappa was calculated separately for each of the five artificial-intelligence configurations and three non-reference expert anaesthesiologists against the pragmatic single-expert reference using the ordered categories successful, patchy/inadequate and failed/no local anaesthetic. Values range from -1 to 1; 1 indicates perfect agreement, 0 indicates agreement expected by chance and negative values indicate less agreement than expected by chance. Each reader assessed each image set once.
Measured: June 2026; each archived image set was assessed once by each reader.
Fleiss Kappa Among AI Configurations and Among Expert Anaesthesiologists
Across all 120 image sets, Fleiss kappa was calculated separately among the five artificial-intelligence configurations and among the three non-reference expert anaesthesiologists using the categories successful, patchy/inadequate and failed/no local anaesthetic. Values range from -1 to 1; 1 indicates perfect agreement, 0 indicates agreement expected by chance and negative values indicate less agreement than expected by chance. Each reader assessed each image set once; within-reader and within-system repeatability were not evaluated.
Measured: June 2026; each archived image set was assessed once by each reader.
Median Postoperative Resting Pain Score on the Numerical Rating Scale
Resting pain was reported verbally as a whole number on an 11-point Numerical Rating Scale from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain. Scores were summarised as median and interquartile range at each scheduled time point. Assessment required the participant to be extubated and able to respond. The planned 6-hour assessment was applicable only when the participant had already been extubated.
Measured: 6, 12, 24 and 48 hours after surgery
Median Postoperative Cough-Evoked Pain Score on the Numerical Rating Scale
Pain during coughing was reported verbally as a whole number on an 11-point Numerical Rating Scale from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain. Scores were summarised as median and interquartile range at each scheduled time point. Assessment required the participant to be extubated and able to respond. The planned 6-hour assessment was applicable only when the participant had already been extubated.
Measured: 6, 12, 24 and 48 hours after surgery
Number of Participants Receiving Additional Rescue Paracetamol
In the 115 participants who received PIFB, rescue paracetamol administration was recorded as a participant-level yes/no measure and was to be summarised as the number and percentage of participants receiving at least one rescue dose. Rescue treatment was administered when NRS exceeded 4 at the attending physician's discretion.
Measured: During the first 48 hours after surgery
Number of Participants Receiving Rescue Tramadol
In the 115 participants who received PIFB, rescue tramadol administration was recorded as a participant-level yes/no measure and was to be summarised as the number and percentage of participants receiving at least one rescue dose. Rescue treatment was administered when NRS exceeded 4 at the attending physician's discretion.
Measured: During the first 48 hours after surgery
Number of Participants Receiving Rescue Pethidine
In the 115 participants who received PIFB, rescue pethidine administration was recorded as a participant-level yes/no measure and was to be summarised as the number and percentage of participants receiving at least one rescue dose. Rescue treatment was administered when NRS exceeded 4 at the attending physician's discretion.
Measured: During the first 48 hours after surgery
Median Intensive Care Unit Length of Stay in Days
Intensive-care length of stay was the recorded number of days from postoperative intensive-care admission until intensive-care discharge and was summarised as median and interquartile range in the PIFB-treated cohort.
Measured: From postoperative intensive-care admission to intensive-care discharge, up to 13 days after surgery
Median Index Hospital Length of Stay in Days
Hospital length of stay was the recorded number of days from coronary artery bypass grafting until discharge from the index hospital admission and was summarised as median and interquartile range in the PIFB-treated cohort.
Measured: From surgery to hospital discharge, up to 25 days after surgery
Number of Participants With at Least One Postoperative Complication
In the 115 participants who received PIFB, postoperative complications recorded during the index hospital admission were summarised as the number and percentage of participants with at least one event.
Measured: From surgery through hospital discharge during the index admission, up to 25 days after surgery
Number of Participants Who Died During the Index Hospital Admission
In the 115 participants who received PIFB, mortality was summarised as the number and percentage of participants who died before discharge from the index hospital admission.
Measured: From surgery through hospital discharge during the index admission, up to 25 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Sep 2025
- Primary completion27 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anıl Onur, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581678
- Sponsor's protocol ID
- 2024-TBEK 2025/08-14
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level analysis data underlying the reader-performance and longitudinal pain analyses, together with statistical analysis code and derived machine-readable outputs, will be made available to qualified researchers on reasonable request after publication. Ultrasound images are not included in this sharing plan.
Publications
Bowness JS, Burckett-St Laurent D, Hernandez N, Keane PA, Lobo C, Margetts S, Moka E, Pawa A, Rosenblatt M, Sleep N, Taylor A, Woodworth G, Vasalauskaite A, Noble JA, Higham H. Assistive artificial intelligence for ultrasound image interpretation in regional anaesthesia: an external validation study. Br J Anaesth. 2023 Feb;130(2):217-225. doi: 10.1016/j.bja.2022.06.031. Epub 2022 Aug 18.
PubMed 35987706Jean WH, Sutikno P, Fan SZ, Abbod MF, Shieh JS. Comparison of Deep Learning Algorithms in Predicting Expert Assessments of Pain Scores during Surgical Operations Using Analgesia Nociception Index. Sensors (Basel). 2022 Jul 23;22(15):5496. doi: 10.3390/s22155496.
PubMed 35897999Hargrave J, Grant MC, Kolarczyk L, Kelava M, Williams T, Brodt J, Neelankavil JP. An Expert Review of Chest Wall Fascial Plane Blocks for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2023 Feb;37(2):279-290. doi: 10.1053/j.jvca.2022.10.026. Epub 2022 Nov 1.
PubMed 36414532Capuano P, Sepolvere G, Toscano A, Scimia P, Silvetti S, Tedesco M, Gentili L, Martucci G, Burgio G. Fascial plane blocks for cardiothoracic surgery: a narrative review. J Anesth Analg Crit Care. 2024 Mar 11;4(1):20. doi: 10.1186/s44158-024-00155-5.
PubMed 38468350
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Evaluation of Anatomical Success of Fascial Plane Blocks Applied in Open Heart Surgery and Investigation of Its Relationship With Postoperative Pain Scores: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07581678
- Acronym / sponsor ID
- 2024-TBEK 2025/08-14
- Conditions
- Coronary Artery Disease, Postoperative Pain
- Keywords
- artificial intelligence, multimodal AI, ultrasonography, regional anaesthesia, pecto-intercostal fascial plane block, coronary artery bypass grafting, postoperative pain, reader study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 12 May 2026 (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 prospective observational cohort with a nested archived-image reader study compared the sonographic pecto-intercostal fascial plane block classifications of five general-purpose multimodal artificial-intelligence configurations and three expert anaesthesiologists against a separate senior anaesthesiologist's single-expert reference. Adults undergoing elective isolated coronary artery bypass grafting through median sternotomy were enrolled consecutively on days when the consultant anaesthesiologist responsible for block performance and ultrasound acquisition was available. Standardised left-sided ultrasound videos were recorded in 120 consented participants. Bilateral pecto-intercostal fascial plane block was performed in 115 participants; five participants who declined the block consented to standardised ultrasound imaging and served as no-block image controls. Eight to ten representative de-identified frames from each video were assessed independently by all readers. Associations between reference-defined sonographic spread and postoperative pain were secondary and observational.
Detailed description
This single-centre prospective observational cohort included 120 consenting adults undergoing elective isolated coronary artery bypass grafting through median sternotomy. At the end of surgery, after complete sternal and skin closure, 115 participants received bilateral ultrasound-guided pecto-intercostal fascial plane block with 20 mL of 0.25% bupivacaine on each side (40 mL and 100 mg in total). Five participants declined the block but consented to Ethics Committee-authorised standardised ultrasound imaging, storage and subsequent de-identified human/AI assessment; no needle was inserted and no local anaesthetic was administered in this group.
Ultrasound videos were acquired from the left side with an M5 portable ultrasound system and a 7L4s linear-array transducer at a nominal frequency of 7.5 MHz using standardised settings. Eight to ten representative frames were selected from each video across the pre-block view, needle advancement, local-anaesthetic spread and final post-injection view, as applicable. The same frame set and fixed participant order were shown to every reader.
After participant follow-up had ended, five general-purpose multimodal AI configurations, three expert anaesthesiologists and one separate senior reference anaesthesiologist independently classified each image set as successful, patchy/inadequate or failed/no local anaesthetic. The evaluated configurations were Gemini 3.5 Flash, Claude Sonnet 4.6, GPT-5.5 Instant in ChatGPT, Grok 4.3 and Kimi K2.6. They were accessed through free, non-subscription consumer accounts using their standard web interfaces and default response and data-use settings. For each system-participant pair, a new conversation was opened, the same fixed prompt and image set were submitted, and the first response was recorded without regeneration or re-prompting. The visible conversation was deleted before the next assessment, although this did not establish provider-side deletion. Each configuration assessed each participant once; within-system repeatability was not evaluated. The number and identities of the five consumer configurations were fixed before any reader output was observed; no bespoke AI model was developed or trained. The separate senior anaesthesiologist was a pragmatic single-expert reference and not an objective gold standard. The study was not designed as an equivalence or non-inferiority analysis.
Postoperative Numerical Rating Scale pain at rest and during coughing was scheduled at 6, 12, 24 and 48 hours. The 6-hour assessment was applicable only to participants who had already been extubated at that time. Rescue analgesic administration during the first 48 hours, intensive-care and hospital length of stay, complications and mortality were also recorded. Pain associations were secondary, observational and non-causal.
The ClinicalTrials.gov record was first submitted on 6 May 2026 and first posted on 12 May 2026, after the study had begun but while recruitment, image acquisition and clinical follow-up were still ongoing. Registration was therefore retrospective relative to study start. Image acquisition ended on 27 May 2026 and participant clinical follow-up ended on 1 June 2026.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIFB-Treated Cohort | – | Procedure: Pecto-Intercostal Fascial Plane BlockOne hundred fifteen consenting adults undergoing elective isolated coronary artery bypass grafting received bilateral ultrasound-guided pecto-intercostal fascial plane block at the end of surgery. Their archived ultrasound image sets were included in the principal reader-performance and secondary clinical analyses. |
| Consented No-Block Image Controls | – | –Five participants declined pecto-intercostal fascial plane block and consented to Ethics Committee-authorised standardised ultrasound imaging and research/AI assessment. No needle was inserted and no local anaesthetic was administered. Their image sets were included in the same reader series as the treated cohort. They were excluded from treated-cohort binary reader-performance and pain analyses. These participants were no-block image controls, not attempted-block failures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective isolated coronary artery bypass grafting through median sternotomy. On days when the consultant anaesthesiologist responsible for pecto-intercostal fascial plane block and ultrasound acquisition was available, every eligible patient was invited consecutively.
Key inclusion criteria (4 listed)
- Age 18-80 years
- American Society of Anesthesiologists physical status III
- Scheduled for elective isolated coronary artery bypass grafting through median sternotomy
- Written informed consent for study participation and research/AI assessment of de-identified ultrasound images
Key exclusion criteria (9 listed)
- Emergency surgery
- Redo sternotomy
- Minimally invasive or thoracotomy surgical approach
- Allergy to local anaesthetics
- International normalised ratio greater than 1.5 or platelet count below 80,000 per microlitre
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 |
|---|---|---|
| Pecto-Intercostal Fascial Plane BlockBilateral ultrasound-guided PIFB performed after complete sternal and skin closure as routine clinical care, using 20 mL of 0.25% bupivacaine on each side (40 mL; 100 mg total). | Procedure or surgery | PIFB-Treated Cohort |
Primary outcome
Balanced Accuracy of Binary PIFB Classification Against a Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Among 115 participants who received pecto-intercostal fascial plane block, binary classifications from each of five general-purpose multimodal artificial-intelligence configurations and three expert anaesthesiologists were compared separately with the classification of a senior anaesthesiologist serving as a pragmatic single-expert reference. Successful was the positive category; patchy/inadequate and failed/no local anaesthetic were combined as not successful. Balanced accuracy was calculated as (sensitivity + specificity)/2 and reported from 0 to 1, with higher values indicating closer agreement with the reference. The reference was not an objective gold standard, and no equivalence or non-inferiority hypothesis was tested.
16 secondary outcomes
Sensitivity of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Specificity of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Positive Predictive Value of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Negative Predictive Value of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Overall Accuracy of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Linear-Weighted Cohen Kappa for Three-Category Agreement With the Single-Expert Reference
Time frame: June 2026; each archived image set was assessed once by each reader.
Fleiss Kappa Among AI Configurations and Among Expert Anaesthesiologists
Time frame: June 2026; each archived image set was assessed once by each reader.
Median Postoperative Resting Pain Score on the Numerical Rating Scale
Time frame: 6, 12, 24 and 48 hours after surgery
Median Postoperative Cough-Evoked Pain Score on the Numerical Rating Scale
Time frame: 6, 12, 24 and 48 hours after surgery
Number of Participants Receiving Additional Rescue Paracetamol
Time frame: During the first 48 hours after surgery
Number of Participants Receiving Rescue Tramadol
Time frame: During the first 48 hours after surgery
Number of Participants Receiving Rescue Pethidine
Time frame: During the first 48 hours after surgery
Median Intensive Care Unit Length of Stay in Days
Time frame: From postoperative intensive-care admission to intensive-care discharge, up to 13 days after surgery
Median Index Hospital Length of Stay in Days
Time frame: From surgery to hospital discharge, up to 25 days after surgery
Number of Participants With at Least One Postoperative Complication
Time frame: From surgery through hospital discharge during the index admission, up to 25 days after surgery
Number of Participants Who Died During the Index Hospital Admission
Time frame: From surgery through hospital discharge during the index admission, up to 25 days after surgery
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 11 Sep 2026.
- Background: PubMed 35987706Bowness JS, Burckett-St Laurent D, Hernandez N, Keane PA, Lobo C, Margetts S, Moka E, Pawa A, Rosenblatt M, Sleep N, Taylor A, Woodworth G, Vasalauskaite A, Noble JA, Higham H. Assistive artificial intelligence for ultrasound image interpretation in regional anaesthesia: an external validation study. Br J Anaesth. 2023 Feb;130(2):217-225. doi: 10.1016/j.bja.2022.06.031. Epub 2022 Aug 18.
- Background: PubMed 35897999Jean WH, Sutikno P, Fan SZ, Abbod MF, Shieh JS. Comparison of Deep Learning Algorithms in Predicting Expert Assessments of Pain Scores during Surgical Operations Using Analgesia Nociception Index. Sensors (Basel). 2022 Jul 23;22(15):5496. doi: 10.3390/s22155496.
- Background: PubMed 36414532Hargrave J, Grant MC, Kolarczyk L, Kelava M, Williams T, Brodt J, Neelankavil JP. An Expert Review of Chest Wall Fascial Plane Blocks for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2023 Feb;37(2):279-290. doi: 10.1053/j.jvca.2022.10.026. Epub 2022 Nov 1.
- Background: PubMed 38468350Capuano P, Sepolvere G, Toscano A, Scimia P, Silvetti S, Tedesco M, Gentili L, Martucci G, Burgio G. Fascial plane blocks for cardiothoracic surgery: a narrative review. J Anesth Analg Crit Care. 2024 Mar 11;4(1):20. doi: 10.1186/s44158-024-00155-5.
- Individual participant dataSharing planned: Yes. De-identified participant-level analysis data underlying the reader-performance and longitudinal pain analyses, together with statistical analysis code and derived machine-readable outputs, will be made available to qualified researchers on reasonable request after publication. Ultrasound images are not included in this sharing plan.
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Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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 Coronary Artery Disease and Postoperative Pain, run by Bursa Yuksek Ihtisas 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 4 inclusion and 9 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 11 Sep 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?
Balanced Accuracy of Binary PIFB Classification Against a Single-Expert Reference (time frame: June 2026; each archived image set was assessed once by each reader.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07581678, which also lists 4 linked publications.
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 11 Sep 2026.