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

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Tracheal Stenosis

Treatments: Device: Hydrogen generator treatment; Device: Oxygen-making machine treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02961387

TS20160801

Details and patient eligibility

About

Investigators aim to study the effectiveness and safety of inhaling hydrogen-oxygen which produced by a hydrogen generator with nebulizer to decreases inspiratory effort for the patients with tracheal stenosis.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged from 18 to 65;
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

1. Those who were suffered from respiratory failure or more severe caused by dyspnea;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Hydrogen generator treatment

Experimental group

Description:

Inhalation of hydrogen-oxygen mixed gas.

Treatment:

Device: Oxygen-making machine treatment

Device: Hydrogen generator treatment

Oxygen-making machine treatment

Sham Comparator group

Description:

Inhalation of oxygen.

Treatment:

Device: Oxygen-making machine treatment

Device: Hydrogen generator treatment