Tracheal StenosisNCT02961387
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
A study testing Hydrogen generator treatment and Oxygen-making machine treatment in people with Tracheal Stenosis, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- Hydrogen generator treatment and Oxygen-making machine treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120
Ziqing Zhou, doctor, +86 13535580261, zhou.ziqing@foxmail.com
About this 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
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.
- Conditions
- Tracheal Stenosis
- Being tested
- Hydrogen generator treatment, Oxygen-making machine treatment
- Keywords
- Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.
- Medical subject headings
- Tracheal Stenosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen generator treatmentDevice
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
Oxygen-making machine treatmentDevice
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen generator treatment | Experimental | Inhalation of hydrogen-oxygen mixed gas. Receives: Device: Hydrogen generator treatment; Device: Oxygen-making machine treatment |
| Oxygen-making machine treatment | Sham comparator | Inhalation of oxygen. Receives: Device: Hydrogen generator treatment; Device: Oxygen-making machine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Secondary outcomes (8)
Change in Borg score for dyspnea after inhalation.
Measured: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in symptom of dyspnea from baseline after inhalation.
Changes in comfort with each gas mixture were evaluated by a simple questionnaire
Measured: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
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.
Measured: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in PaO2, PaCO2, PH& HCO3- after inhalation
Change in Arterial blood gases.
Measured: Baseline and 150min
FEV1 & FVC
Forced expiratory volume in one second \& Forced vital capacity.
Measured: Baseline
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
Measured: Baseline and inhaling
Change in cough waves from baseline when inhaling
Cough waves will be recorded by a voice recorder.
Measured: Baseline, Inhaling.
Grades of airway stenosis by bronchoscopy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961387
- Sponsor's protocol ID
- TS20160801
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02961387
- Acronym / sponsor ID
- TS20160801
- Conditions
- Tracheal Stenosis
- Keywords
- Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen generator treatment | Experimental | Device: Hydrogen generator treatment, Device: Oxygen-making machine treatmentInhalation of hydrogen-oxygen mixed gas. |
| Oxygen-making machine treatment | Sham comparator | Device: Hydrogen generator treatment, Device: Oxygen-making machine treatmentInhalation of oxygen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen generator treatmentThe patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas. | Device | Hydrogen generator treatment, Oxygen-making machine treatment |
| Oxygen-making machine treatmentThe patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation. | Device | Hydrogen generator treatment, Oxygen-making machine treatment |
Primary outcome
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.
8 secondary outcomes
Change in Borg score for dyspnea after inhalation.
Time frame: 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
Change in signs(BR, HR, BP, el) from baseline after inhalation
Time frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in PaO2, PaCO2, PH& HCO3- after inhalation
Time frame: Baseline and 150min
FEV1 & FVC
Time frame: Baseline
Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling.
Time frame: Baseline and inhaling
Change in cough waves from baseline when inhaling
Time frame: Baseline, Inhaling.
Grades of airway stenosis by bronchoscopy
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen generator treatment and Oxygen-making machine treatment in people with Tracheal Stenosis, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziqing Zhou, Doctor (+86 13535580261, zhou.ziqing@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.