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Record W4387164922 · doi:10.1164/rccm.202304-0637oc

High-Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure Due to COVID-19: A Multicenter Phase II Trial

2023· article· en· W4387164922 on OpenAlexfundno aff
Raffaele Di Fenza, Naman S. Shetty, Stefano Gianni, Vibhu Parcha, Valentina Giammatteo, Bijan Safaee Fakhr, Daniel C. Törnberg, Olof Wall, Piotr Harbut, Peggy S. Lai, Jonathan Z. Li, Sabrina Paganoni, Stefano Cenci, Ariel Mueller, Timothy T. Houle, Oluwaseun Akeju, Edward A. Bittner, Somnath Bose, L. Keith Scott, Ryan W. Carroll, Fumito Ichinose, Magnus Hedenstierna, Pankaj Arora, Lorenzo Berra

Bibliographic record

VenueAmerican Journal of Respiratory and Critical Care Medicine · 2023
Typearticle
Languageen
FieldMedicine
TopicRespiratory Support and Mechanisms
Canadian institutionsnot available
FundersNational Institutes of HealthMassachusetts Consortium on Pathogen ReadinessLouisiana State University ShreveportMallinckrodt PharmaceuticalsUniversity of Alabama at BirminghamNational Institute of Allergy and Infectious DiseasesLouisiana State UniversityBeth Israel Deaconess Medical CenterMassachusetts General HospitalFoundation for the National Institutes of HealthLinde's Global Giving Program
KeywordsMedicineCoronavirus disease 2019 (COVID-19)2019-20 coronavirus outbreakSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Nitric oxideMulticenter studyIntensive care medicineInternal medicineRandomized controlled trialVirology

Abstract

fetched live from OpenAlex

Abstract Rationale The effects of high-dose inhaled nitric oxide on hypoxemia in coronavirus disease (COVID-19) acute respiratory failure are unknown. Objectives The primary outcome was the change in arterial oxygenation (PaO2/Fi O2) at 48 hours. The secondary outcomes included: time to reach a PaO2/Fi O2.300mmHg for at least 24 hours, the proportion of participants with a PaO2/Fi O2.300mmHg at 28 days, and survival at 28 and at 90 days. Methods Mechanically ventilated adults with COVID-19 pneumonia were enrolled in a phase II, multicenter, single-blind, randomized controlled parallel-arm trial. Participants in the intervention arm received inhaled nitric oxide at 80 ppm for 48 hours, compared with the control group receiving usual care (without placebo). Measurements and Main Results A total of 193 participants were included in the modified intention-to-treat analysis. The mean change in PaO2/Fi O2 ratio at 48 hours was 28.3mmHg in the intervention group and 21.4mmHg in the control group (mean difference, 39.1mmHg; 95% credible interval [CrI], 18.1 to 60.3). The mean time to reach a PaO2/Fi O2.300mmHg in the interventional group was 8.7 days, compared with 8.4 days for the control group (mean difference, 0.44; 95% CrI, 23.63 to 4.53). At 28 days, the proportion of participants attaining a PaO2/Fi O2.300mmHg was 27.7% in the inhaled nitric oxide group and 17.2% in the control subjects (risk ratio, 2.03; 95% CrI, 1.11 to 3.86). Duration of ventilation and mortality at 28 and 90 days did not differ. No serious adverse events were reported. Conclusions The use of high-dose inhaled nitric oxide resulted in an improvement of PaO2/Fi O2 at 48 hours compared with usual care in adults with acute hypoxemic respiratory failure due to COVID-19.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.006
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.282
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.006
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0020.002
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

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.

Opus teacher head0.033
GPT teacher head0.368
Teacher spread0.335 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designRandomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations45
Published2023
Admission routes1
Has abstractyes

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