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A Cross-over study to compare the Lung Flute method with hypertonic saline inhalation for the examination of M. tuberculosis in induced sputum

Phase 3
Conditions
Pulmonary tuberculosis
Registration Number
JPRN-UMIN000004676
Lead Sponsor
Sputum Induction Research Group
Brief Summary

Total of 63 patients were analyzed. A crossover study of the Lung Flute method (LF) and hypertonic saline inhalation (HSI) demonstrated no significant difference in grading of smear, positive culture rate, time to positivity (days), and PCR positivity between LF and HSI. The Lung Flute method was equivalent in terms of bacteriological diagnosis to hypertonic saline inhalation in hospitalized patients with tuberculosis.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

1. ABF sputum smear 3+ before admission 2. Patients who expectorate sputum at any time 3. Laryngeal tuberculosis 4. Bronchial asthma 5. Hemoptysis 6. Respiratory failure (Spo2 below 90% on breathing room air) 7. Pneumothorax 8. Hyperventilation syndrome (including past history) 9. Poorly controlled hypertension 10. Unable to understand sputum induction 11. Inability to follow sputum induction instruction 12. Pregnant women 13. Unsuitable for participation by the decision of the responsible doctors 14. Over days after the start of TB treatment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The results of AFB smear, culture, and TB PCR in (induced) sputum
Secondary Outcome Measures
NameTimeMethod
1. Success rate of sputum induction and timing of expectoration 2. Condition and amount of sputum 3. Oxygen saturation before and after sputum induction 4. Adverse events
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