Clinical trial NCT02961387: 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
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheal Stenosis
Keywords: Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study.
timeFrame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Secondary outcomes:
measure: Change in Borg score for dyspnea after inhalation.
timeFrame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
measure: Change in symptom of dyspnea from baseline after inhalation.
timeFrame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
measure: Change in signs(BR, HR, BP, el) from baseline after inhalation
timeFrame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
measure: Change in PaO2, PaCO2, PH& HCO3- after inhalation
timeFrame: Baseline and 150min
measure: FEV1 & FVC
timeFrame: Baseline
measure: Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling.
timeFrame: Baseline and inhaling
measure: Change in cough waves from baseline when inhaling
timeFrame: Baseline, Inhaling.
measure: Grades of airway stenosis by bronchoscopy
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
References: