Size matters: first-in-human study of a novel 4 French REBOA device
Bibliographic record
Abstract
BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the feasibility of a novel 4 French REBOA device called the COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System). METHODS: This study is the first-in-human feasibility trial of the COBRA-OS. Due to the difficulty of trialing the device in the trauma setting, we performed a feasibility study using organ donors (due to the potential usefulness of the COBRA-OS for normothermic regional perfusion) after neurological determination of death (NDD) prior to organ retrieval. Bilateral 4 French introducer sheaths were placed in both femoral arteries and the COBRA-OS was advanced up the right side and deployed in the thoracic aorta (Zone 1). Once aortic occlusion was confirmed via the left-sided arterial line, the device was deflated, moved to the infrarenal aorta (Zone 3), and redeployed. RESULTS: A total of 7 NDD organ donors were entered into the study, 71% men, with a mean age 46.6 years (range 26 to 64). The COBRA-OS was able to occlude the aorta in Zones 1 and 3 in all patients. The mean time of placing a 4 French sheath was 47.7 seconds (n=13, range 28 to 66 seconds). The mean time from skin to Zone 1 aortic occlusion was 70.1 seconds (range 58 to 105 seconds); mean balloon volumes were 15 mL for Zone 1 (range 13 to 20 mL) and 9 mL for Zone 3 (range 6 to 15 mL); there were no complications and visual inspection of the aorta in all patients revealed no injury. DISCUSSION: The COBRA-OS is a novel 4 French REBOA device that has demonstrated fast and safe aortic occlusion in this first-in-human feasibility study. LEVEL OF EVIDENCE: Level V, therapeutic.
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.010 | 0.002 |
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".