Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen generator treatment | Experimental | Inhalation of hydrogen-oxygen mixed gas. |
|
| Oxygen-making machine treatment | Sham Comparator | Inhalation of oxygen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen generator treatment | Device | The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Borg score for dyspnea after inhalation. | Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | |
| Change in symptom of dyspnea from baseline after inhalation. | Changes in comfort with each gas mixture were evaluated by a simple questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Quit criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziqing Zhou, Doctor | Contact | +86 13535580261 | zhou.ziqing@foxmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease | Recruiting | Guangzhou | Guangdong | 510120 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxygen-making machine treatment | Device | The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation. |
|
| Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min |
| 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 |
| Change in PaO2, PaCO2, PH& HCO3- after inhalation | Change in Arterial blood gases. | Baseline and 150min |
| FEV1 & FVC | Forced expiratory volume in one second & Forced vital capacity. | Baseline |
| 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 |
| Change in cough waves from baseline when inhaling | Cough waves will be recorded by a voice recorder. | Baseline, Inhaling. |
| Grades of airway stenosis by bronchoscopy | baseline |
| ID | Term |
|---|---|
| D014135 | Tracheal Stenosis |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided