Tracheal Stenosis Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Guangzhou Institute of Respiratory Disease | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Institute of Respiratory Disease |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study. | sRMSdi/para/sc: root-mean-square of diaphragm/parasternal/sternocleidomastoid surface electromyography; RMSdi: root-mean-square of diaphragm electromyography; Pdi: Transdiaphragmatic pressure; MIP:maximal inspiratory pressure. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | Yes |
Secondary | Change in Borg score for dyspnea after inhalation. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | No | |
Secondary | Change in symptom of dyspnea from baseline after inhalation. | Changes in comfort with each gas mixture were evaluated by a simple questionnaire | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | No |
Secondary | Change in signs(BR, HR, BP, el) from baseline after inhalation | Change in signs include breath rate, heart rate, blood pressure,Three Depression Sign and so on. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | No |
Secondary | Change in PaO2, PaCO2, PH& HCO3- after inhalation | Change in Arterial blood gases. | Baseline and 150min | No |
Secondary | FEV1 & FVC | Forced expiratory volume in one second & Forced vital capacity. | Baseline | No |
Secondary | Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling. | R5 - Resistance at 5Hz, R20 - Resistance at 20Hz, X5 - Reactance at 5Hz, RF - Frequency of resonance, AX - Area under reactance curve | Baseline and inhaling | No |
Secondary | Change in cough waves from baseline when inhaling | Cough waves will be recorded by a voice recorder. | Baseline, Inhaling. | No |
Secondary | Grades of airway stenosis by bronchoscopy | baseline | No |
Status | Clinical Trial | Phase | |
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