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

Not Applicable

• Conditions: Tracheal Stenosis
• Interventions: Device: Hydrogen generator treatment; Device: Oxygen-making machine treatment

• Registration Number: NCT02961387
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Study First Posted: 2016-11-11
• Last Update Posted: 2016-11-11
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrogen generator treatment	Hydrogen generator treatment	Inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatment	Hydrogen generator treatment	Inhalation of oxygen.
Hydrogen generator treatment	Oxygen-making machine treatment	Inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatment	Oxygen-making machine treatment	Inhalation of oxygen.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Grades of airway stenosis by bronchoscopy	baseline
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.	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.
FEV1 & FVC	Baseline	Forced expiratory volume in one second \& Forced vital capacity.
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.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China