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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorChen, Yao-Hsiang

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Nebulization therapy

    Other intervention

    Comparison of different concentrations of saline solutions used for nebulization therapy

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: Hypertonic groupActive comparator 1 intervention
Group C: Isotonic groupActive comparator 1 intervention
Group D: Hypotonic groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vein blood gas

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

Time frame
Measurements were performed before the intervention and at 7 days after the intervention.
2

Sputum routine examination

Assessment of sputum characteristics and routine laboratory findings.

Time frame
Measurements were performed before the intervention and at 7 days after the intervention.
3

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

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

Secondary outcomes

1

Blood lactic acid level

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Chen, Yao-Hsiang

Lead sponsor

Tri-Service General Hospital

Sponsor institution

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