Bronchoalveolar LavageSTABALNCT04200742
Standardized BAL Procedure for Critical Patients to Diagnose Pneumonia Pathogens
An observational study of Bronchoalveolar Lavage and Pneumonia, run by Wu Jianfeng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bronchoalveolar Lavage, Pneumonia
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is selected from the Departement of Critical Care Medicine of the First Affiliated Hospital of Sun Yat-sen University.
Who may be able to join
- Admitted to intensive care unit
- Mechanically ventilated patient
- 18 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 ℃;
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wu Jianfeng, M.D, 020-87755766 ext. 8454, wujiafeng9571@163.com
Guan Xiangdong, M.D, 020-87755766 ext. 8456, carlg@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchoalveolar Lavage, Pneumonia
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 days
Secondary outcomes (7)
Quality of BALF samples, evaluated by counts of different kind of cells in BALF
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.
Measured: 24 hours
Recovery of bronchoalveolar lavage fluid
To record the volume of bronchoalveolar lavage fluid (BALF) recovered and calculate the recovery.
Measured: 1 hour
Impact of bronchoalveolar lavage (BAL) on the cardiovascular system.
To observe the systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), mean arterial pressure (MAP) and heart rate (HR).
Measured: 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).
Cst will be measured with mechanical ventilator (Drager EvitaXL, Germany).
Measured: 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.
Chang of airway resistance (Raw).
Raw will be measured with mechanical ventilator (Drager EvitaXL, Germany).
Measured: 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL.
Change of PaO2/FiO2 ratio.
PaO2 denotes the arterial oxygen partial pressure and FiO2 denotes the fraction of inspired oxygen.
Measured: 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).
PaCO2 will be measured by arterial blood gas analysis.
Measured: About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start16 Sep 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoalveolar LavageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Jianfeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wu Jianfeng, Sun Yat-sen University
- Investigators
- Jianfeng Wu, M.D, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200742
- Sponsor's protocol ID
- Standard BAL
- Acronym
- STABAL
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Standardized Procedure of Bronchoalveolar Lavage on the Diagnosis of Pneumonia Pathogen of Critical Patients
- ClinicalTrials.gov ID
- NCT04200742
- Acronym / sponsor ID
- STABAL / Standard BAL
- Conditions
- Bronchoalveolar Lavage, Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wu JianfengUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is selected from the Departement of Critical Care Medicine of the First Affiliated Hospital of Sun Yat-sen University.
Key inclusion criteria (9 listed)
- Admitted to intensive care unit
- Mechanically ventilated patient
- 18 years old or above
- Pneumonia diagnosed by one of 1 - 4 plus 5
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
7 secondary outcomes
Quality of BALF samples, evaluated by counts of different kind of cells in BALF
Time frame: 24 hours
Recovery of bronchoalveolar lavage fluid
Time frame: 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
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.
Chang of airway resistance (Raw).
Time frame: 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Wu, M.D study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoalveolar Lavage and Pneumonia, run by Wu Jianfeng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Wu, M.D (020-87755766 ext. 8454, wujianfeng9571@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.