Menu
Not yet recruiting NCT07586345

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

No phase Interventional Pneumonia Airway Clearance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nebulization therapy.
Who it may be relevant to
Registry conditions: Pneumonia, Airway Clearance. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Nebulization therapy
    Comparison of different concentrations of saline solutions used for nebulization therapy

Primary outcome measures

  • Vein blood gas [Time frame: Measurements were performed before the intervention and at 7 days after the intervention.]
  • Sputum routine examination [Time frame: Measurements were performed before the intervention and at 7 days after the intervention.]
  • Arterial oxygen content (CaO₂) [Time frame: Measurements were performed before the intervention and at 7 days after the intervention.]
Secondary outcome measures (1)
  • Blood lactic acid level [Time frame: Measurements were performed before the intervention and at 7 days after the intervention.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07586345 · TSGH-SS_D_115024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗