Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study
Bibliographic record
Abstract
INTRODUCTION: Peripheral vascular disease (PVD) is a condition caused by arterial blockages causing inadequate blood flow, resulting in pain and gangrene of the legs. Endovascular therapy, such as angioplasty, can be used to treat PVD, however, the operator feedback during surgery is primarily anatomic based on the angiogram. Because physiologic blood perfusion can be difficult to determine based on anatomic images, we propose introducing physiological measurements into the operating room. This study will investigate whether the change in intraoperative monitoring of haemodynamic measurements such as the Toe-Brachial Index during endovascular surgery for lower extremity atherosclerotic PVD is associated with clinical outcomes such as major adverse limb events (MALEs). METHODS AND ANALYSIS: This study will be a prospective, operator-blinded and blinded endpoint adjudicated observational diagnostic cohort study. A total of 80 legs will be enrolled in the study. Ankle and toe blood pressures will be measured non-invasively at predetermined time points before, during and after surgery, and we will assess associations between changes in intraoperative pressure measurements and postoperative clinical and haemodynamic outcomes. The primary outcome will be MALE within 1 year, and secondary outcomes include follow-up pressure measurements, vessel patency, reintervention, clinical staging improvement, amputation and death. ETHICS AND DISSEMINATION: Regional hospital ethics approval has been granted (Ottawa Hospital Research Institute - Research Ethics Board, Protocol 20180656-01H). On completion of data analysis, the study will submitted for presentation at international vascular surgical society meetings, in addition to submission for publication in publicly accessible medical journals. TRIAL REGISTRATION NUMBER: NCT03875846.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.025 | 0.023 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.041 | 0.016 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".