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A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects
Published on: May 4, 2021
Multicenter randomized controlled trial of inhaled nitric oxide for pediatric acute respiratory distress syndrome
Ronald A Bronicki1, James Fortenberry2, Michael Schreiber3
1Pediatric Critical Care Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.
Insights
Inhaled nitric oxide (iNO) improved survival free from extracorporeal membrane oxygenation and reduced mechanical ventilation duration in pediatric acute respiratory distress syndrome. This study highlights iNO
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Physiology
- Pharmacology
Background:
- Acute respiratory distress syndrome (ARDS) in children presents significant challenges.
- Mechanical ventilation and extracorporeal membrane oxygenation (ECMO) are life-support measures with associated morbidities.
- Identifying novel therapeutic strategies to improve outcomes in pediatric ARDS is crucial.
Purpose of the Study:
- To evaluate the efficacy of inhaled nitric oxide (iNO) in improving oxygenation.
- To assess the impact of iNO on the duration of mechanical ventilation.
- To determine the effect of iNO on survival and need for ECMO in pediatric ARDS patients.
Main Methods:
- A randomized controlled trial involving 55 pediatric patients diagnosed with ARDS.
- Patients were assigned to receive either inhaled nitric oxide (iNO) or placebo.
- Treatment continued until death, liberation from mechanical ventilation, or day 28.
Main Results:
- A trend towards improved oxygenation index (OI) was observed in the iNO group, becoming significant at 12 hours.
- Patients receiving iNO had significantly more days alive and free from mechanical ventilation at 28 days (P = .05).
- Extracorporeal membrane oxygenation-free survival was significantly higher in the iNO group (P < .01).
Conclusions:
- Inhaled nitric oxide (iNO) significantly reduces the duration of mechanical ventilation in pediatric ARDS.
- iNO is associated with a significantly greater rate of survival free from extracorporeal membrane oxygenation.
- These findings suggest iNO as a potential adjunctive therapy for pediatric ARDS.
Objectives:
To test the hypothesis that inhaled nitric oxide (iNO) would lead to improved oxygenation and a decrease in duration of mechanical ventilation in pediatric patients with acute respiratory distress syndrome.
Study Design:
A total of 55 children with acute respiratory distress syndrome were enrolled from 9 centers. Patients were randomized to iNO or placebo and remained on the study drug until death, they were free of ventilator support, or day 28 after the initiation of therapy.
Results:
Mean baseline oxygenation indexes (OIs) were 22.0 ± 18.4 and 25.6 ± 14.9 (iNO and placebo groups, respectively, P = .27). There was a trend toward an improved OI in the iNO group compared with the placebo group at 4 hours that became significant at 12 hours. There was no difference in the OI between groups at 24 hours. Days alive and ventilator free at 28 days was greater in the iNO group, 14.2 ± 8.1 and 9.1 ± 9.5 days (iNO and placebo groups, respectively, P = .05). Although overall survival at 28 days failed to reach statistical significance, 92% (22 of 24) in the iNO group and 72% (21 of 29) in the placebo group (P = .07), the rate of extracorporeal membrane oxygenation-free survival was significantly greater in those randomized to iNO 92% (22 of 24) vs 52% (15 of 29) for those receiving placebo (P < .01).
Conclusion:
The use of iNO was associated with a significantly reduced duration of mechanical ventilation and significantly greater rate of extracorporeal membrane oxygenation-free survival.
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