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

Guangzhou Institute of Respiratory Disease1 site in 1 country50 target enrollmentNovember 2016

ConditionsTracheal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tracheal Stenosis
Sponsor: Guangzhou Institute of Respiratory Disease
Enrollment: 50
Locations: 1
Primary Endpoint: Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study.
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

June 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Guangzhou Institute of Respiratory Disease

Responsible Party

Principal Investigator

ShiYue Li

Professor of Guangzhou Institute of Respiratory Disease

Guangzhou Institute of Respiratory Disease

Eligibility Criteria

Inclusion Criteria

•Aged from 18 to 65;
•Diagnosed moderate/severe tracheal stenosis by chest CT and/or bronchoscopy;
•Difficulty breathing symptoms
•Agree to participate in this trial and sign the informed consent form.

Exclusion Criteria

•Those who were suffered from respiratory failure or more severe caused by dyspnea;
•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);
•Those who were suffered from severe mental illness or could not take care of themselves;
•Pregnant or lactating women;
•Those who could not understand the trial procedures and correctly the trial equipment;
•Those who participated in other clinical trials in the first 3 months before the screening date.
•Quit criteria
•The subjects requiring emergency intubation or other intervention or surgical treatment due to worsened tracheal stenosis;
•Subjects who had severe adverse events during treatment;
•Subjects who did not want to continue to participate in the trial;

Outcomes

Primary Outcomes

Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study.

Time Frame: 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 Outcomes

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)
Change in signs(BR, HR, BP, el) from baseline after inhalation(Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min)
Change in PaO2, PaCO2, PH& HCO3- after inhalation(Baseline and 150min)
FEV1 & FVC(Baseline)
Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling.(Baseline and inhaling)
Change in cough waves from baseline when inhaling(Baseline, Inhaling.)
Grades of airway stenosis by bronchoscopy(baseline)