A Clinical Trial on Effectiveness and Safety of Hydrogen Generator to Treat Dyspnea for the Patients With Tracheal Stenosis: A Randomized, Double-blind and Single-center Clinical Study
NCT ID: NCT02961387
Last Updated: 2016-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-11-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Hydrogen generator treatment
Inhalation of hydrogen-oxygen mixed gas.
Hydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Oxygen-making machine treatment
Inhalation of oxygen.
Hydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Interventions
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Hydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed moderate/severe tracheal stenosis by chest CT and/or bronchoscopy;
3. Difficulty breathing symptoms
4. Agree to participate in this trial and sign the informed consent form.
Exclusion Criteria
2. Combined other serious systemic diseases (severe arrhythmia, acute myocardial ischemia, uncontrollable hypertension crisis, active gastric ulcer, uncontrolled diabetes, renal failure, blood system diseases or coagulation dysfunction);
3. Those who were suffered from severe mental illness or could not take care of themselves;
4. Pregnant or lactating women;
5. Those who could not understand the trial procedures and correctly the trial equipment;
6. Those who participated in other clinical trials in the first 3 months before the screening date.
Quit criteria
1. The subjects requiring emergency intubation or other intervention or surgical treatment due to worsened tracheal stenosis;
2. Subjects who had severe adverse events during treatment;
3. Subjects who did not want to continue to participate in the trial;
4. The subjects who were necessarily terminated for the trial by the investigators.
18 Years
65 Years
ALL
No
Sponsors
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Guangzhou Institute of Respiratory Disease
OTHER
Responsible Party
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ShiYue Li
Professor of Guangzhou Institute of Respiratory Disease
Locations
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Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ziqing Zhou, doctor
Role: primary
Other Identifiers
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TS20160801
Identifier Type: -
Identifier Source: org_study_id