Standardized BAL Procedure for Critical Patients to Diagnose Pneumonia Pathogens (STABAL)

December 13, 2019 updated by: Wu Jianfeng

The Influences of Standardized Procedure of Bronchoalveolar Lavage on the Diagnosis of Pneumonia Pathogen of Critical Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a self-control study consisted of three parts. Firstly, searching for the optimal lavage volume in the middle lobe and the lower lobe of critical patients by exploring the differences between the concentration of alveolar proteins among BALF samples of every participant. Several BALF samples are seperately collected from every single participant through sequential lavage(an initial 20 ml saline lavage at main bronchus and 5 aliquots of 20 ml saline lavage at the subsegment of the right middle lobe or 6 aliquots of 20 ml saline lavage at the lower lobe) . The concentration of Alveolar proteins including Surfactant protein B (SP-B), Surfactant protein D (SP-D) and Human typeⅠprotein (HTⅠ-56) will be determined by enzyme-linked immunosorbent assay (ELISA). Meanwhile, the amount of living cells as well as the proportion of squamous cells and columnar cells in BALF samples will be counted. Secondly, to confirm the optimal lavage volume through quantitative bacterial culture of BALF and sputum samples of participants. And BALF samples will also be tested by next generation sequencing（NGS） to identify microorganism. Thirdly, to observe the effect of BAL on respiratory and cardiovascular systems. The Vital signs, arterial gas analysis, ventilator parameters and respiratory mechanical parameters of patients before and within 24 hours after the BAL procedure will be recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
          • Guan Xiangdong, M.D
          • Phone Number: 8456 020-87755766
          • Email: carlg@163.com
        • Principal Investigator:
          • Wu Jianfeng, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Admitted to intensive care unit
  • Mechanically ventilated patient
  • 18 years old or above

  • Pneumonia diagnosed by one of 1 - 4 plus 5

    1. purulent endotracheal secretions or increasing oxygen requirements;
    2. body temperature exceeds 38.0 ℃;
    3. potentially pathogenic bacteria be isolated from the endotracheal secretions;
    4. leukocyte count exceeds 10×10^9 per liter or less than 4×10^9 per liter;
    5. new or persistent radiographic features of pneumonia without another obvious cause.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 48 hours
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.
Time Frame: 3 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of BALF samples, evaluated by counts of different kind of cells in BALF
Time Frame: 24 hours
The living cells of BALF will be counted by Trypan blue staining. And the proportion of squamous cell and columnar cell will be counted by Wright-Giemsa staining.
24 hours
Recovery of bronchoalveolar lavage fluid
Time Frame: 1 hour
To record the volume of bronchoalveolar lavage fluid (BALF) recovered and calculate the recovery.
1 hour
Impact of bronchoalveolar lavage (BAL) on the cardiovascular system.
Time Frame: 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours, 19 hours and 24 hours after BAL
To observe the systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), mean arterial pressure (MAP) and heart rate (HR).
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).
Time Frame: 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.
Cst will be measured with mechanical ventilator (Drager EvitaXL, Germany).
30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.
Chang of airway resistance (Raw).
Time Frame: 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.
Raw will be measured with mechanical ventilator (Drager EvitaXL, Germany).
30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.
Change of PaO2/FiO2 ratio.
Time Frame: About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL.
PaO2 denotes the arterial oxygen partial pressure and FiO2 denotes the fraction of inspired oxygen.
About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL.
Change of arterial carbon dioxide partial pressure (PaCO2).
Time Frame: About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL.
PaCO2 will be measured by arterial blood gas analysis.
About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wu Jianfeng

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jianfeng Wu, M.D, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Standard BAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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