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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2016
• Main ID: NCT02961387
• Date of registration: 02/11/2016
• Prospective Registration: No
• Primary sponsor: Guangzhou Institute of Respiratory Disease
• Public title: 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
• Scientific title: A Clinical Trial on Effectiveness and Safety of Inhaling Hydrogen-oxygen to Decreases Inspiratory Effort for the Patients With Tracheal Stenosis: A Randomized, Double-blind and Single-center Clinical Study
• Date of first enrolment: November 2016
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02961387
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Ziqing Zhou, doctor

• Name: Ziqing Zhou, Doctor

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tracheal Stenosis

Intervention(s)

Device: Hydrogen generator treatment

Device: Oxygen-making machine treatment

Primary Outcome(s)

Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study. [Time Frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min]

Secondary Outcome(s)

Change in PaO2, PaCO2, PH& HCO3- after inhalation [Time Frame: Baseline and 150min]

Change in signs(BR, HR, BP, el) from baseline after inhalation [Time Frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min]

FEV1 & FVC [Time Frame: Baseline]

Grades of airway stenosis by bronchoscopy [Time Frame: baseline]

Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling. [Time Frame: Baseline and inhaling]

Change in Borg score for dyspnea after inhalation. [Time Frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min]

Change in symptom of dyspnea from baseline after inhalation. [Time Frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min]

Change in cough waves from baseline when inhaling [Time Frame: Baseline, Inhaling.]

Secondary ID(s)

TS20160801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors