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

Phase 1

Recruiting

• Conditions: Acute respiratory distress syndrome

• Registration Number: JPRN-jRCTs062220003
• Lead Sponsor: akao Atsunori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified