NCT02961387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

November 2, 2016

Last Update Submit

November 8, 2016

Conditions

Tracheal Stenosis

Keywords

Tracheal stenosis, Hydrogen generator, Hydrogen-oxygen, Dyspnea.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Hydrogen generator treatment

EXPERIMENTAL

Inhalation of hydrogen-oxygen mixed gas.

Device: Hydrogen generator treatmentDevice: Oxygen-making machine treatment

Oxygen-making machine treatment

SHAM COMPARATOR

Inhalation of oxygen.

Device: Hydrogen generator treatmentDevice: Oxygen-making machine treatment

Interventions

Hydrogen generator treatmentDEVICE

The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.

Hydrogen generator treatmentOxygen-making machine treatment
Oxygen-making machine treatmentDEVICE

The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.

Hydrogen generator treatmentOxygen-making machine treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Tracheal StenosisDyspnea

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ziqing Zhou, Doctor

CONTACT

+86 13535580261zhou.ziqing@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Guangzhou Institute of Respiratory Disease

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 11, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations

CN(1)