Trial reportBMC anesthesiology2026
Performance of an indigenously developed high-flow nasal cannula device in healthy human volunteers.
Trial report in BMC anesthesiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
backgroundHigh Flow Nasal Cannula (HFNC) therapy provides clinical and physiological benefits, particularly in the management of acute respiratory failure. However, the performance of indigenously developed HFNC systems remains underexplored. This study evaluates the safety and efficacy of oxygenation with a novel Indian-manufactured HFNC device in healthy adult volunteers.
methodsIn this single-centre, participant-blinded, randomised, phase 0 study, 21 healthy volunteers, predominantly male participants; findings may not generalise. They were assigned to receive oxygen via an HFNC device at flow rates of 20, 40, or 60 LPM. Each participant received sequential FiO₂ levels of 0.40, 0.60, 0.80, and 1.00, with pre- and post-intervention ABG sampling at each stage. Physiological variables, including pO₂, pH, heart rate, and blood pressure, were monitored. Predicted pO₂ values were calculated.
resultsAll participants completed the study without adverse events. A significant, linear increase in arterial pO₂ was observed with rising FiO₂ across all flow groups (p < 0.001), consistent with predicted values (Spearman correlation coefficient: 0.74). No significant increase in pO₂ was noted with flow rate changes alone, as expected in healthy individuals. All vital parameters remained within normal clinical limits.
conclusionThe device demonstrated effective oxygenation and safety in healthy volunteers, with good participant tolerance. These findings support further clinical evaluation in patient populations and regulatory validation.
trial registrationCTRI/2024/02/062209, dated: 01/02/2024.
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