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Background <p>High 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.</p> Methods <p>In 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.</p> Results <p>All participants completed the study without adverse events. A significant, linear increase in arterial pO₂ was observed with rising FiO₂ across all flow groups (<i>p</i> &lt; 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.</p> Conclusion <p>The 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.</p> Trial registration <p>CTRI/2024/02/062209, dated: 01/02/2024.</p>

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Performance of an indigenously developed high-flow nasal cannula device in healthy human volunteers

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月16日

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  • Shiv Lal Soni,
  • Goverdhan Dutt Puri,
  • Venkata Ganesh,
  • Ajay Singh,
  • Naveen Naik Banavathu,
  • Narender Kaloria,
  • Harpreet Singh,
  • Soumya Vij,
  • Avaneesh Kumar Pandey,
  • Nusrat Shafiq

摘要

Background

High 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.

Methods

In 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.

Results

All 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.

Conclusion

The 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 registration

CTRI/2024/02/062209, dated: 01/02/2024.