Bronchoalveolar LavageNCT05403489
Comparison of the Results of Bronchoalveolar Lavage Culture and Endotracheal Aspirate Culture in Intubated Critically Ill COVID-19 Patients
An observational study of Bronchoalveolar Lavage and COVID-19 Pneumonia, run by Basri Cakiroglu at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Secondary pneumonia is frequently seen in COVID-19 cases followed up intubated, and high mortality rates can be observed. Isolation of the agent with bronchoalveolar lavage (BAL) culture or endotracheal aspirate (ETA) culture may increase the success of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoalveolar Lavage, COVID-19 Pneumonia, Critical Illness
- What is being tested?
- Bronchoalveolar lavage and endotracheal aspirate culture
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who were intubated due to COVID 19 in our reanimation unit between January 2021 and December 2021 and underwent BAL or ETA analysis were retrospectively scanned from the hospital information management system and patient files.
Who may be able to join
- Intubated COVID-19 patients
- Above 18 years old patients
Who cannot join
- Non COVID-19 patients
- Non intubated COVID-19 patients
- Below 18 years old patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Introduction: Secondary pneumonia is frequently seen in COVID-19 cases followed up intubated, and high mortality rates can be observed. Isolation of the agent with bronchoalveolar lavage (BAL) culture or endotracheal aspirate (ETA) culture may increase the success of treatment. This study aimed to retrospectively analyze the results of BAL and ETA cultures in intubated COVID-19 cases.
Methods: We routinely apply BAL culture with bronchoscopy or ETA culture within the first 48 hours after intubating. We retrospectively screened cases who underwent BAL and ETA. They were divided into two groups: Group B and E. Evaluated parameters were compared in both groups.
Read more
Results: Demographic data and blood test results were similar in both groups. Intensive care unit (ICU) and intubation durations, and culture positivity were statistically significantly higher in Group B. Although not statistically significant, the mortality rate was higher in Group E. The most growth microorganisms were Candida species.
Conclusion: Mortality rates were consistent with the literature. Since the microorganism isolation rate is higher with BAL and antimicrobial treatment is applied more effectively; early deaths were prevented and stay periods were prolonged. In contrast, these durations were shorter in the ETA group due to higher mortality. In intubated COVID-19 cases, a more effective treatment process can be carried out by clearing the airway with fiberoptic bronchoscopy and by specifically planning the treatment according to the BAL culture. This may have a positive effect on prognosis and mortality.
- Conditions
- Bronchoalveolar Lavage, COVID-19 Pneumonia, Critical Illness
- Being tested
- Bronchoalveolar lavage, endotracheal aspirate culture
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavageProcedure or surgery
Also called Bronchoalveolar lavage culture, fiberoptic bronchoscopy
In cases approved for bronchoscopy, bronchoalveolar lavage was performed and culture analysis was performed.
endotracheal aspirate cultureProcedure or surgery
In cases where consent for bronchoscopy could not be obtained, tracheal secretions were aspirated and culture analysis was performed.
| Study group | Role | What they receive |
|---|---|---|
| Group B (bronchoalveolar lavage) | Patients who underwent BAL* were named Group B
* BAL: bronchoalveolar lavage Receives: Procedure: Bronchoalveolar lavage | |
| Group E (endotracheal aspirate) | Patients who received ETA** were named Group E.
** ETA: Endotracheal aspirate Receives: Procedure: endotracheal aspirate culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture positivity
Significantly higher microbiological culture growth rate was obtained in Group B
Measured: 1 years
Length of stay in intensive care unit
Significantly higher duration of stay in intensive care unit was found in Group B
Measured: 1 years
Duration of intubation
Significantly higher duration of stay intubated was observed in Group B
Measured: 1 years
Mortality
Mortality rate was higher in Group E. But not statistically significant.
Measured: 1 years
Secondary outcomes (1)
Microorganism
The most growing microorganism in both groups was the Candida species.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 May 2022
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basri Cakiroglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
- Investigators
- Hasan Huseyin Kilic, Principal investigator, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403489
- Sponsor's protocol ID
- HisarIH
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Results of Bronchoalveolar Lavage Culture and Endotracheal Aspirate Culture in Intubated Critically Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05403489
- Acronym / sponsor ID
- HisarIH
- Conditions
- Bronchoalveolar Lavage, COVID-19 Pneumonia, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Basri CakirogluUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Jun 2022 (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.
Introduction: Secondary pneumonia is frequently seen in COVID-19 cases followed up intubated, and high mortality rates can be observed. Isolation of the agent with bronchoalveolar lavage (BAL) culture or endotracheal aspirate (ETA) culture may increase the success of treatment. This study aimed to retrospectively analyze the results of BAL and ETA cultures in intubated COVID-19 cases.
Methods: We routinely apply BAL culture with bronchoscopy or ETA culture within the first 48 hours after intubating. We retrospectively screened cases who underwent BAL and ETA. They were divided into two groups: Group B and E. Evaluated parameters were compared in both groups.
Results: Demographic data and blood test results were similar in both groups. Intensive care unit (ICU) and intubation durations, and culture positivity were statistically significantly higher in Group B. Although not statistically significant, the mortality rate was higher in Group E. The most growth microorganisms were Candida species.
Conclusion: Mortality rates were consistent with the literature. Since the microorganism isolation rate is higher with BAL and antimicrobial treatment is applied more effectively; early deaths were prevented and stay periods were prolonged. In contrast, these durations were shorter in the ETA group due to higher mortality. In intubated COVID-19 cases, a more effective treatment process can be carried out by clearing the airway with fiberoptic bronchoscopy and by specifically planning the treatment according to the BAL culture. This may have a positive effect on prognosis and mortality.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B (bronchoalveolar lavage) | – | Procedure: Bronchoalveolar lavagePatients who underwent BAL* were named Group B * BAL: bronchoalveolar lavage |
| Group E (endotracheal aspirate) | – | Procedure: endotracheal aspirate culturePatients who received ETA** were named Group E. ** ETA: Endotracheal aspirate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were intubated due to COVID 19 in our reanimation unit between January 2021 and December 2021 and underwent BAL or ETA analysis were retrospectively scanned from the hospital information management system and patient files.
Key inclusion criteria (2 listed)
- Intubated COVID-19 patients
- Above 18 years old patients
Key exclusion criteria (3 listed)
- Non COVID-19 patients
- Non intubated COVID-19 patients
- Below 18 years old patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar lavageAlso: Bronchoalveolar lavage culture, fiberoptic bronchoscopyIn cases approved for bronchoscopy, bronchoalveolar lavage was performed and culture analysis was performed. | Procedure or surgery | Group B (bronchoalveolar lavage) |
| endotracheal aspirate cultureIn cases where consent for bronchoscopy could not be obtained, tracheal secretions were aspirated and culture analysis was performed. | Procedure or surgery | Group E (endotracheal aspirate) |
Primary outcome
Culture positivity
Time frame: 1 years
Significantly higher microbiological culture growth rate was obtained in Group B
Length of stay in intensive care unit
Time frame: 1 years
Significantly higher duration of stay in intensive care unit was found in Group B
Duration of intubation
Time frame: 1 years
Significantly higher duration of stay intubated was observed in Group B
Mortality
Time frame: 1 years
Mortality rate was higher in Group E. But not statistically significant.
1 secondary outcome
Microorganism
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Hasan Huseyin Kilic principal investigator
Hisar Intercontinental Hospital
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 COVID-19 Pneumonia, run by Basri Cakiroglu at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jun 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture positivity (time frame: 1 years). The study lists 4 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 3 Jun 2022.