Rationale for Use of an FDA-Cleared Delivery System for Administration of Inhaled Nitric Oxide in Patients Undergoing Magnetic Resonance Imaging
Bibliographic record
Abstract
Abstract: Inhaled nitric oxide (iNO) is a pulmonary vasodilator approved for use to improve lung function in neonates > 34 weeks’ gestational age with hypoxic respiratory failure and pulmonary hypertension. Infants with severe respiratory disease frequently require magnetic resonance imaging (MRI) scans for evaluation of treatment and diagnosis of concurrent disease processes. Until 2015, incompatibility between the standard iNO delivery system components and the magnetic field within the MRI setting required iNO treatment to be interrupted for MRI, which could increase risk of deoxygenation and rebound pulmonary hypertension. In some cases, patients had to forego or delay MRI in order to maintain uninterrupted iNO delivery. The US Food and Drug Administration cleared the first iNO delivery system specifically modified for conditional use with MRI scanners (INOmax DS IR ® Plus MRI) in 2015, based on the determination that the MRI-cleared system met the performance standards equivalent to the standard system. The system design and manufacturer risk management activities, as well as the regulatory requirements for clearance and continued use, provide necessary safeguards to ensure that high-risk neonates receive uninterrupted iNO in a safe manner. Anecdotal reports suggest that adoption of the MRI-cleared system may help optimize care for critically ill neonates who require concurrent administration of iNO and MRI scanning. Further research will be necessary to quantify the nature and magnitude of clinical improvements associated with adoption of the MRI iNO delivery system. Keywords: critical care, drug delivery systems, magnetic resonance imaging, newborn, nitric oxide
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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 | 0.007 | 0.019 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.009 | 0.003 |
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".