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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Airway Clearance
• Intervention / Treatment: Other: Nebulization therapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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

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

Exclusion Criteria:

1. 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

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

   U07.1: COVID-19, virus identified

3. History of chronic obstructive pulmonary disease (COPD) (ICD-10 code: J44)
4. History of lung cancer or metastatic cancer involving the lungs
5. Current use of bronchodilators
6. Patients requiring oral suctioning only
7. Oxygen therapy with a flow rate > 10 L/min
8. Clinical respiratory score > 8 (Table 2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Other: Nebulization therapy; Comparison of different concentrations of saline solutions used for nebulization therapy
Active Comparator: Hypertonic group	Other: Nebulization therapy; Comparison of different concentrations of saline solutions used for nebulization therapy
Active Comparator: Isotonic group	Other: Nebulization therapy; Comparison of different concentrations of saline solutions used for nebulization therapy
Active Comparator: Hypotonic group	Other: Nebulization therapy; Comparison of different concentrations of saline solutions used for nebulization therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vein blood gas	Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.	Measurements were performed before the intervention and at 7 days after the intervention.
Sputum routine examination	Assessment of sputum characteristics and routine laboratory findings.	Measurements were performed before the intervention and at 7 days after the intervention.
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	Measurements were performed before the intervention and at 7 days after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lactic acid level	Measurement of serum lactic acid concentration. Unit of Measure: mmol/L	Measurements were performed before the intervention and at 7 days after the intervention.

Collaborators and Investigators

• Sponsor: Chen, Yao-Hsiang

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: TSGH-SS_D_115024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No