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

November 8, 2016 updated by: ShiYue Li, Guangzhou Institute of Respiratory Disease

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangzhou Institute of Respiratory Disease
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrogen generator treatment
Inhalation of hydrogen-oxygen mixed gas.
Device: Hydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Device: Oxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Sham Comparator: Oxygen-making machine treatment
Inhalation of oxygen.
Device: Hydrogen generator treatment
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Device: Oxygen-making machine treatment
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Borg score for dyspnea after inhalation.
Time Frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in symptom of dyspnea from baseline after inhalation.
Time Frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Changes in comfort with each gas mixture were evaluated by a simple questionnaire
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in signs(BR, HR, BP, el) from baseline after inhalation
Time Frame: 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.
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in PaO2, PaCO2, PH& HCO3- after inhalation
Time Frame: Baseline and 150min
Change in Arterial blood gases.
Baseline and 150min
FEV1 & FVC
Time Frame: Baseline
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.
Time Frame: Baseline and 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
Time Frame: Baseline, Inhaling.
Cough waves will be recorded by a voice recorder.
Baseline, Inhaling.
Grades of airway stenosis by bronchoscopy
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS20160801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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