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A Randomized Controlled Clinical Study of Hydrogen and Oxygen Mixture Used to Improve Mechanical Work and Lung Compliance in ARDS Patients

A Randomized Controlled Clinical Study of Hydrogen and Oxygen Mixture Used to Improve Mechanical Work and Lung Compliance in ARDS Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055763
Enrollment
Unknown
Registered
2022-01-19
Start date
2022-01-19
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

acute respiratory distresssyndrome,ARDS

Interventions

Hydrogen and oxygen mixture treatment group:Hydrogen and oxygen mixture treatment group
countrol group:oxygen treatment

Sponsors

Lianyungang First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years, inclusive; no gender limitation; 2. Within one week of onset, there are known clinical manifestations of impaired respiratory system or new/aggravated respiratory symptoms; 3. Chest imaging shows that the light transmittance of both lungs is weakened, which cannot be fully explained by pleural effusion, lobar pneumonia, atelectasis, pulmonary nodules, etc.; 4. Respiratory failure cannot be fully explained by heart failure or excessive fluid, except for pulmonary edema caused by increased hydrostatic pressure; 5. Blood gas analysis: P/F <= 300 mmHg; 6. Mechanical ventilation therapy (invasive or non-invasive); 7. The patient or the legal representative signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Women during pregnancy or lactation; 2. The expected survival time of patients due to underlying diseases is less than 28 days, such as terminal malignant tumors, cardiac arrest within 30 days before enrollment, and terminal lung disease; 3. The patient has the following chronic organ dysfunction or immunosuppression (according to the chronic health score assessment of APACHE II score): (1) Heart: Heart function class IV of the New York Heart Association; (2) Respiration: Chronic obstructive, obstructive or vascular pulmonary disease causes severe limitation of usual activities, that is, unable to go upstairs or unable to do housework; or clear chronic hypoxia, CO2 retention, secondary polycythemia vera, severe Pulmonary hypertension (> 40 mmHg) or ventilator dependence; (3) Kidney: receive long-term dialysis treatment; (4) Liver: biopsy confirmed liver cirrhosis and clear portal hypertension; previous upper gastrointestinal bleeding caused by portal hypertension; or previous liver failure/hepatic encephalopathy/hepatic coma; (5) Immune function suppression: The received treatment measures affect the resistance to infection (such as immunosuppressive therapy, chemotherapy, radiotherapy, long-term or short-term use of high-dose hormones), or the disease affects the resistance to infection (such as leukemia, lymphoma and AIDS) (6) Solid organ or bone marrow transplantation; (7) Plant survival status; 4. The following situations occurred within 4 weeks before enrollment: (1) Acute pulmonary embolism; (2) Blood transfusion reaction; (3) Acute coronary syndrome; 5. The patient and/or the legal representative sign the Do Not Rescue (DNR), or decide to withdraw the life support treatment (withdraw) or limit the life support treatment intensity (withhold) and sign the relevant informed consent; 6. Patients who are considered unsuitable to participate in this trial by the attending doctor.

Design outcomes

Primary

MeasureTime frame
mechanical power;Lung compliance;

Secondary

MeasureTime frame
Days of survive within 28 days;No mechanical ventilation days within 28 days;Trend of RALE score and LUS score level at 0, 3 and 7 days after treatment;Trend of inflammatory cytokines IL-6 and IL-10 levels at 0, 3 and 7 days after treatment;

Countries

China

Contacts

Public ContactLi Xiaomin

Lianyungang First People's Hospital

lyglxm1@163.com+86 18961329000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026