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A study on safety and efficacy of high-flow nasal cannula attachable hydrogen gas generator for ARDS

A study on safety and efficacy of high-flow nasal cannula attachable hydrogen gas generator for acute respiratory distress syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062220003
Enrollment
40
Registered
2022-04-12
Start date
2023-01-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome Acute respiratory distress syndrome

Interventions

Incidence of death and invasive mechanical ventilation from the start of hydrogen administration to 10 days

Sponsors

Nakao Atsunori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are 20 years of age or older at the time of consent 2. Patients diagnosed with acute respiratory distress syndrome 3. Patients for whom high-flow nasal cannula is indicated 4. Patients who can perform hydrogen gas inhalation therapy within 48 hours after diagnosis of acute respiratory distress syndrome 5. Patients from whom written consent can be obtained either directly or through a surrogate decision maker.

Exclusion criteria

Exclusion criteria: 1. Patients with traumatic acute respiratory distress syndrome. 2. Patients who have received hydrogen gas inhalation within 1 month. 3. Patients with endotracheal intubation tube or tracheostomy tube. 4. Patients with bilateral nasal obstruction or nasal cavity damage. 5. Patients with severe chronic liver dysfunction equivalent to Grade C in the Child-Pugh classification. 6. Patients with chronic renal dysfunction requiring dialysis (Newly started hemodialysis due to the present illness is not treated as an exclusion criterion). 7. Patients who have started or will start invasive mechanical ventilation or ECMO. 8. Patients with chronic lung disorders requiring home oxygen therapy (Newly started oxygen therapy due to the present illness is not treated as an exclusion criterion). 9. Patients not tolerant to high-flow nasal cannula. 10. Patients with or suspected of having cancer. 11. Women who are pregnant or possibly pregnant. 12. Women who are breastfeeding. 13. Patients who have received other research or investigational drugs within the past 3 months. 14. Other patients who the investigator has determined to be ineligible for this study.

Design outcomes

Primary

MeasureTime frame
Incidence of death and invasive mechanical ventilation from the start of hydrogen administration to 10 days

Secondary

MeasureTime frame
1. Incidence of related adverse event from the start of hydrogen administration to 10 days 2. Respiratory function assessment: AaDO2, PaCO2, respiratory frequency, P/F ratio, Borg index 3. Inflammation assessment: WBC level, body temperature, IL-6, CRP, procalcitonin 4. Medical costs, ICU stay, duration of oxygen therapy requirement, duration of invasive mechanical ventilation.

Contacts

Public ContactToshiyuki Aokage

Okayama University Hospital

t_aokage@okayama-u.ac.jp+81-86-235-7427

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026