Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections

Not Applicable

• Conditions: Lower Respiratory Tract Infections
• Interventions: Procedure: bronchoalveolar lavage 60ml; Procedure: bronchoalveolar lavage 120ml

• Registration Number: NCT02852070
• Lead Sponsor: Capital Medical University

Brief Summary

Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of lower respiratory tract infection.

Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml), including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and other bronchoalveolar lavage related adverse events.

Detailed Description

The morbidity and mortality of lower respiratory tract infection gradually increased in recent years, but the etiological diagnosis rate is still low. Quickly identifying the pathogenic bacteria and the corresponding antimicrobial therapy treatment is particularly important. Fibrotic bronchoscopy combined with bronchoalveolar lavage (BAL) has become a routine diagnostic tool for pulmonary infections in immunocompromised patients.

The correct operation of bronchoalveolar lavage and normalization of bronchoalveolar lavage fluid is a prerequisite for the exact results of the pathogen of BALF.

American Thoracic Society recommended amount of 100-300ml of saline solution was instilled into the distal bronchial tree in the diagnosis of interstitial lung diseases. But there is no standard of lavage fluid volume in the etiological diagnosis of lower respiratory tract infections, ranging from 60ml to 250ml ever reported in literature.

Less lavage volume would be more safer in patients with lower respiratory tract infections. The investigators hypothesize that microbiological yield would be no significant difference in patients with low volume （60ml) compared with large volume (120ml).

The purpose of this study is to explore a more effective and safer way of bronchoalveolar lavage in lower respiratory tract infection patients, and determine the pathogenic distribution among them.

Study Timeline

• Study First Submitted: 2016-06-21
• Study Start: 2016-07
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14
• Primary Completion: 2018-01
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Clinical diagnosis of lower respiratory infection
2. Indication for bronchoalveolar lavage.

Exclusion Criteria

1. Noninfectious pulmonary infiltration
2. Contraindication of bronchoscopy： Severe heart or pulmonary dysfunction Recent occurrence of myocardial infarction unstable angina pectoris Severe coagulation disorders (DIC), Massive hemoptysis Gastrointestinal bleeding Thrombocytopenia (<50*109/L) Severe superior vena cava obstruction syndrome Aortic aneurysm Multiple pulmonary bulla Extreme exhaustion
3. Diagnosed or highly suspected of tuberculosis infection
4. Researchers think that can not be entered into the group.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
observation group	bronchoalveolar lavage 60ml	Bronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage
control group	bronchoalveolar lavage 120ml	Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage

Primary Outcome Measures

Name	Time	Method
Microbiological yield	2 years	Comparison of microbiological yield of two arms with different BALF volume in patients with lower respiratory tract infection in a multicenter, prospective, randomized, single blind study

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections	2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	2 years	Compare the safety of two groups included incidence of hospital acquired penumonia within 14 days after bronchoscopy, and vital signs, oxygenation, and laboratory tests before and after lavage
Sensitivity and specificity of PCR-based microbiological tests	2 years	Microbiological spectrum of pneumonia diagnosed by PCR, as compared with traditional microbiological methods

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China