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临床试验/NCT07581678
NCT07581678已完成不适用

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

Bursa Yuksek Ihtisas Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Postoperative Pain Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Chronic opioid use for more than 3 months
  • Cognitive dysfunction
  • Pregnancy

研究组 & 干预措施

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.

干预措施: Pecto-Intercostal Fascial Plane Block (Procedure)

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.

结局指标

主要结局

Postoperative Pain Score

时间窗: 48 hours postoperatively

Postoperative pain assessed using the Numerical Rating Scale (NRS) at rest and with coughing at 0, 6, 12, 24 and 48 hours after surgery. NRS ranges from 0 (no pain) to 10 (worst imaginable pain). Assessment at 0 and 6 hours was not evaluable as all patients remained intubated and sedated at these time points.

Balanced Accuracy of Binary PIFB Classification Against a Single-Expert Reference

时间窗: 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.

次要结局

  • Agreement Between AI Models and Human Assessors on Block Quality Scores(Intraoperative)
  • Sensitivity of AI and Expert Binary PIFB Classifications Against a Single-Expert Reference(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(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(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(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(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(June 2026; each archived image set was assessed once by each reader.)
  • Fleiss Kappa Among AI Configurations and Among Expert Anaesthesiologists(June 2026; each archived image set was assessed once by each reader.)
  • Median Postoperative Resting Pain Score on the Numerical Rating Scale(6, 12, 24 and 48 hours after surgery)
  • Median Postoperative Cough-Evoked Pain Score on the Numerical Rating Scale(6, 12, 24 and 48 hours after surgery)
  • Number of Participants Receiving Additional Rescue Paracetamol(During the first 48 hours after surgery)
  • Number of Participants Receiving Rescue Tramadol(During the first 48 hours after surgery)
  • Number of Participants Receiving Rescue Pethidine(During the first 48 hours after surgery)
  • Median Intensive Care Unit Length of Stay in Days(From postoperative intensive-care admission to intensive-care discharge, up to 13 days after surgery)
  • Median Index Hospital Length of Stay in Days(From surgery to hospital discharge, up to 25 days after surgery)
  • Number of Participants With at Least One Postoperative Complication(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(From surgery through hospital discharge during the index admission, up to 25 days after surgery)

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anıl Onur

Principal Investigator

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (2)

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