The Effectiveness of Different Nebulized Solutions on Airway Clearance Function in Patients With Pneumonia

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.

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Key information

Conditions

Pneumonia Airway Clearance Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with pneumonia, defined by ICD-10 codes, including:

J18: Pneumonia, unspecified organism J180: Bronchopneumonia, unspecified organism J181: Lobar pneumonia, unspecified organism J182: Hypostatic pneumonia, unspecified organism J188: Other pneumonia, unspecified organism J189: Pneumonia, unspecified organism

Aged 18-100 years
Clinical respiratory score > 3
Patients unable to expectorate sputum spontaneously and requiring assisted suctioning

Exclusion criteria

Diagnosis of influenza-associated pneumonia, defined by ICD-10 codes, including:

J09X1: Influenza due to identified novel influenza A virus with pneumonia J1001: Influenza due to other identified influenza virus with the same identified influenza viral pneumonia J100: Influenza due to other identified influenza virus with pneumonia

Diagnosis of COVID-19 infection, defined by ICD-10 code:

U07.1: COVID-19, virus identified

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
Oxygen therapy with a flow rate > 10 L/min
Clinical respiratory score > 8 (Table 2)

Treatment and study plan

Nebulization therapy

Other

Comparison of different concentrations of saline solutions used for nebulization therapy

Primary outcomes

Vein blood gas

Time frame: Measurements were performed before the intervention and at 7 days after the intervention.

Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.
Sputum routine examination

Time frame: Measurements were performed before the intervention and at 7 days after the intervention.

Assessment of sputum characteristics and routine laboratory findings.
Arterial oxygen content (CaO₂)

Time frame: Measurements were performed before the intervention and at 7 days after the intervention.

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

Time frame: Measurements were performed before the intervention and at 7 days after the intervention.

Measurement of serum lactic acid concentration. Unit of Measure: mmol/L

Sponsors and collaborators

Lead sponsor

Chen, Yao-Hsiang

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 14, 2026
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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