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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02961387
Other study ID # TS20160801
Secondary ID
Status Recruiting
Phase N/A
First received November 2, 2016
Last updated November 8, 2016
Start date November 2016
Est. completion date June 2018

Study information

Verified date November 2016
Source Guangzhou Institute of Respiratory Disease
Contact Ziqing Zhou, Doctor
Phone +86 13535580261
Email zhou.ziqing@foxmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Hydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.

Locations

Country Name City State
China Guangzhou Institute of Respiratory Disease Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

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
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