About this trial
Pneumonia is a significant global and national health issue, particularly posing a notable threat to elderly population. Accumulation of sputum in pneumonia patients often results in impaired airway clearance, negatively impacting disease management and recovery. Clinically, nebulization therapy is widely employed to facilitate sputum clearance; however, evidence regarding the comparative effectiveness of different nebulized solution concentrations remains limited and inconsistent. Therefore, this study aims to evaluate and compare the clinical effects of nebulized solutions with various osmotic concentrations (3% hypertonic saline, 0.9% normal saline, 0.45% hypotonic saline, and distilled water) on airway clearance in patients with pneumonia. A randomized, double-blind controlled trial design will be used, recruiting 80 patients with pneumonia from a regional teaching hospital in northern Taiwan. Participants will be randomly assigned into four groups, receiving nebulized therapy four times daily over a period of seven days. This study outcome including the length of hospital stay, venous blood gas analysis, routine sputum examination, and arterial oxygen content. The findings of this the study are anticipated to provide evidence-based recommendations for the clinical application of nebulized solutions with different concentrations, aiming to enhance airway clearance efficiency, improve clinical care outcomes for pneumonia patients, and serve as a practical reference for healthcare professionals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-100 years
Clinical respiratory score > 3
Patients unable to expectorate sputum spontaneously and requiring assisted suctioning
Disqualifiers
History of chronic obstructive pulmonary disease (COPD) (ICD-10 code: J44)
History of lung cancer or metastatic cancer involving the lungs
Current use of bronchodilators
Patients requiring oral suctioning only
Trial design
Parallel
Treatments tested in this trial
Nebulization therapy
Other interventionComparison of different concentrations of saline solutions used for nebulization therapy
Treatment groups
Trial outcomes
Primary outcomes
Vein blood gas
Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.
Sputum routine examination
Assessment of sputum characteristics and routine laboratory findings.
Arterial oxygen content (CaO₂)
Measurement of arterial oxygen content calculated from hemoglobin concentration, oxygen saturation, and partial pressure of oxygen. Unit of Measure: mL O₂/dL blood
Secondary outcomes
Blood lactic acid level
Measurement of serum lactic acid concentration. Unit of Measure: mmol/L
Locations
Sponsors and contacts
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Chen, Yao-Hsiang
Lead sponsor
Tri-Service General Hospital
Sponsor institution
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