NCT07581678Completed
Five Multimodal AI Configurations Versus Expert Anaesthesiologists for Classifying Pecto-Intercostal Fascial Plane Block Spread in CABG
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 6 May 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 27 May 2026
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07581678
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 1 Sept 2025 to the primary completion date, 27 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery
- Minimally invasive or thoracotomy surgical approach
Other illness
- Allergy to local anaesthetics
- Infection at the planned injection site
Lab values
- International normalised ratio greater than 1.5 or platelet count below 80,000 per microlitre
Other
- Redo sternotomy
- Chronic opioid use for more than 3 months
- Cognitive dysfunction
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Coordinator of this site? Confirm its status | Yıldırım | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.