Standardized BAL Procedure for Critical Patients to Diagnose Pneumonia Pathogens

NCT04200742 | Unknown

• 1 other identifier: Standard BAL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In order to improve the accuracy of the diagnosis of pulmonary pathogens and reduce the adverse impact of excessive BAL volume on patients, this study intends to explore the most optimal lavage volume in the middle lobe and the lower lobe of critical patients as well as seeking for the best way to manage BALF samples by means of detecting alveolar proteins and bacterial composition in BALF samples. The hypothesis is that the optimal lavage volume in the middle lobe and the lower lobe might be different. And to sample BALF separately through sequential lavage might be a better way to improve the accuracy of the diagnosis of pneumonia pathogens.

Conditions

Bronchoalveolar Lavage; Pneumonia

Outcome Measures

Primary Outcomes (2)

• The optimal lavage volume at the middle lobe and the lower lobe, evaluated by the detection of SP-B, SP-D and HTⅠ-56 in bronchoalveolar lavage fluid (BALF).

  For the reason that SP-B, SP-D and HTⅠ-56 only exists in terminal airway and alveolus, the concentrations of them in BALF indicates the abundance of terminal airway materials obtained by bronchoalveolar lavage. SP-B, SP-D and HTⅠ-56 will be detected by enzyme-linked immunosorbent assay (ELISA).

  48 hours

• The best way to manage BALF samples, evaluated by comparing the bacterial diversity and abundance in separately collected BALF specimens and mixed BALF specimen.

  Mixed BALF specimen was a mixture of one tenth of separately collected BALF specimens. The BALF specimens will be cultured at 37℃，5% carbon dioxide for 18 to 24 hours, using blood ager, chocolate ager and MacConkey ager. Bacterial species will be identified by matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) and the colony counts will be recorded. Besides, BALF specimens will also be dectected by Next Generation Sequencing for the bacterial diversity and abundance. As a reference, culture of the endotracheal aspiration will be conducted.

  3 days

Secondary Outcomes (7)

• Quality of BALF samples, evaluated by counts of different kind of cells in BALF

  24 hours

• Recovery of bronchoalveolar lavage fluid

  1 hour

• Impact of bronchoalveolar lavage (BAL) on the cardiovascular system.

  30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours, 19 hours and 24 hours after BAL

• Change of pulmonary static compliance (Cst).

  30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.

• Chang of airway resistance (Raw).

  30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is selected from the Departement of Critical Care Medicine of the First Affiliated Hospital of Sun Yat-sen University.

You may qualify if:

• Admitted to intensive care unit
• Mechanically ventilated patient
• years old or above
• Pneumonia diagnosed by one of 1 - 4 plus 5
• purulent endotracheal secretions or increasing oxygen requirements;
• body temperature exceeds 38.0 ℃;
• potentially pathogenic bacteria be isolated from the endotracheal secretions;
• leukocyte count exceeds 10×10\^9 per liter or less than 4×10\^9 per liter;
• new or persistent radiographic features of pneumonia without another obvious cause.

You may not qualify if:

• considered to be unsuitable for bronchoscopy by attending physician;
• underwent bronchoalveolar lavage within the last 48 hours;
• medical history of lobectomy
• airway bleeding or pulmonary edema
• refuse to sign the informed consent

Sponsors & Collaborators

• Wu Jianfeng: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid, which is sampled by bronchoalveolar lavage.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianfeng Wu, M.D

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Jianfeng Wu, M.D

CONTACT

020-87755766; wujianfeng9571@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 16, 2019
• Study Start: September 16, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

CN (1)