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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, China
RECRUITINGChange 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.
Time frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
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.
Changes in comfort with each gas mixture were evaluated by a simple questionnaire
Time frame: 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.
Time frame: Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min
Change in PaO2, PaCO2, PH& HCO3- after inhalation
Change in Arterial blood gases.
Time frame: Baseline and 150min
FEV1 & FVC
Forced expiratory volume in one second \& Forced vital capacity.
Time frame: 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
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Time frame: Baseline and inhaling
Change in cough waves from baseline when inhaling
Cough waves will be recorded by a voice recorder.
Time frame: Baseline, Inhaling.
Grades of airway stenosis by bronchoscopy
Time frame: baseline