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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961387
• Other study ID #: TS20160801
• 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

• Constriction, Pathologic
• Tracheal Stenosis

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