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

JRCT ID: jRCTs062220003

Registered date:12/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute respiratory distress syndrome
• Date of first enrollment: 26/01/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Incidence of death and invasive mechanical ventilation from the start of hydrogen administration to 10 days

Outcome(s)

• Primary Outcome: Incidence of death and invasive mechanical ventilation from the start of hydrogen administration to 10 days

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nakao Atsunori
• Source(s) of Monetary Support: Japan Society for Emergency Medicine,Takeda Science Foundation