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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

Primary Purpose

Tracheal Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrogen generator treatment
Oxygen-making machine treatment
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheal Stenosis focused on measuring Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangzhou Institute of Respiratory DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Hydrogen generator treatment

Oxygen-making machine treatment

Arm Description

Inhalation of hydrogen-oxygen mixed gas.

Inhalation of oxygen.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Borg score for dyspnea after inhalation.
Change in symptom of dyspnea from baseline after inhalation.
Changes in comfort with each gas mixture were evaluated by a simple questionnaire
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.
Change in PaO2, PaCO2, PH& HCO3- after inhalation
Change in Arterial blood gases.
FEV1 & FVC
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.
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
Cough waves will be recorded by a voice recorder.
Grades of airway stenosis by bronchoscopy

Full Information

First Posted
November 2, 2016
Last Updated
November 8, 2016
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT02961387
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Stenosis
Keywords
Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrogen generator treatment
Arm Type
Experimental
Arm Description
Inhalation of hydrogen-oxygen mixed gas.
Arm Title
Oxygen-making machine treatment
Arm Type
Sham Comparator
Arm Description
Inhalation of oxygen.
Intervention Type
Device
Intervention Name(s)
Hydrogen generator treatment
Intervention Description
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Intervention Type
Device
Intervention Name(s)
Oxygen-making machine treatment
Intervention Description
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Primary Outcome Measure Information:
Title
Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study.
Description
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.
Time Frame
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Secondary Outcome Measure Information:
Title
Change in Borg score for dyspnea after inhalation.
Time Frame
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Title
Change in symptom of dyspnea from baseline after inhalation.
Description
Changes in comfort with each gas mixture were evaluated by a simple questionnaire
Time Frame
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Title
Change in signs(BR, HR, BP, el) from baseline after inhalation
Description
Change in signs include breath rate， heart rate， blood pressure，Three Depression Sign and so on.
Time Frame
Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Title
Change in PaO2, PaCO2, PH& HCO3- after inhalation
Description
Change in Arterial blood gases.
Time Frame
Baseline and 150min
Title
FEV1 & FVC
Description
Forced expiratory volume in one second & Forced vital capacity.
Time Frame
Baseline
Title
Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling.
Description
R5 - Resistance at 5Hz, R20 - Resistance at 20Hz, X5 - Reactance at 5Hz, RF - Frequency of resonance, AX - Area under reactance curve
Time Frame
Baseline and inhaling
Title
Change in cough waves from baseline when inhaling
Description
Cough waves will be recorded by a voice recorder.
Time Frame
Baseline, Inhaling.
Title
Grades of airway stenosis by bronchoscopy
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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; The subjects who were necessarily terminated for the trial by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziqing Zhou, Doctor
Phone
+86 13535580261
Email
zhou.ziqing@foxmail.com
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziqing Zhou, doctor
Phone
+86 13535580261
Email
zhou.ziqing@foxmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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