Tracheal Stenosis
Conditions
Keywords
Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.
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.
Interventions
DEVICEHydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
DEVICEOxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom of dyspnea from baseline after inhalation. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | Changes in comfort with each gas mixture were evaluated by a simple questionnaire |
| Change in signs(BR, HR, BP, el) from baseline after inhalation | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | Change in signs include breath rate， heart rate， blood pressure，Three Depression Sign and so on. |
| Change in PaO2, PaCO2, PH& HCO3- after inhalation | Baseline and 150min | Change in Arterial blood gases. |
| Change in Borg score for dyspnea after inhalation. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | — |
| Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling. | Baseline and inhaling | R5 - Resistance at 5Hz, R20 - Resistance at 20Hz, X5 - Reactance at 5Hz, RF - Frequency of resonance, AX - Area under reactance curve |
| Change in cough waves from baseline when inhaling | Baseline, Inhaling. | Cough waves will be recorded by a voice recorder. |
| Grades of airway stenosis by bronchoscopy | baseline | — |
| FEV1 & FVC | Baseline | Forced expiratory volume in one second & Forced vital capacity. |
Countries
China
Contacts
Primary ContactZiqing Zhou, Doctor
Outcome results
None listed