---
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"
nct_id: NCT02961387
overall_status: UNKNOWN
phase: NA
sponsor: Guangzhou Institute of Respiratory Disease
study_type: INTERVENTIONAL
primary_condition: Tracheal Stenosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02961387.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02961387"
ct_last_update_post_date: 2016-11-11
last_seen_at: "2026-05-12T06:38:35.690Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02961387](https://clinicaltrials.gov/study/NCT02961387)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Guangzhou Institute of Respiratory Disease
- **Conditions:** Tracheal Stenosis
- **Start Date:** 2016-11
- **Completion Date:** 2018-06
- **CT.gov Last Update:** 2016-11-11

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Hydrogen generator treatment** (EXPERIMENTAL) — Inhalation of hydrogen-oxygen mixed gas.
- **Oxygen-making machine treatment** (SHAM_COMPARATOR) — Inhalation of oxygen.

## Interventions

- **Hydrogen generator treatment** (DEVICE) — The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
- **Oxygen-making machine treatment** (DEVICE) — The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.

## 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.** _(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)_

## Locations (1)

- Guangzhou Institute of Respiratory Disease, Guangzhou, Guangdong, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.guangzhou institute of respiratory disease|guangzhou|guangdong|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02961387.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02961387*  
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