NCT05403489

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 2, 2022

Last Update Submit

June 2, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Culture positivity

    Significantly higher microbiological culture growth rate was obtained in Group B

    1 years

  • Length of stay in intensive care unit

    Significantly higher duration of stay in intensive care unit was found in Group B

    1 years

  • Duration of intubation

    Significantly higher duration of stay intubated was observed in Group B

    1 years

  • Mortality

    Mortality rate was higher in Group E. But not statistically significant.

    1 years

Secondary Outcomes (1)

  • Microorganism

    1 years

Study Arms (2)

Group B (bronchoalveolar lavage)

Patients who underwent BAL\* were named Group B \* BAL: bronchoalveolar lavage

Procedure: Bronchoalveolar lavage

Group E (endotracheal aspirate)

Patients who received ETA\*\* were named Group E. \*\* ETA: Endotracheal aspirate

Procedure: endotracheal aspirate culture

Interventions

In cases approved for bronchoscopy, bronchoalveolar lavage was performed and culture analysis was performed.

Also known as: Bronchoalveolar lavage culture, fiberoptic bronchoscopy
Group B (bronchoalveolar lavage)

In cases where consent for bronchoscopy could not be obtained, tracheal secretions were aspirated and culture analysis was performed.

Group E (endotracheal aspirate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Intubated COVID-19 patients
  • Above 18 years old patients

You may not qualify if:

  • Non COVID-19 patients
  • Non intubated COVID-19 patients
  • Below 18 years old patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Hasan Huseyin Kilic

    Hisar Intercontinental Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hisar Intercontinental Hospital

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 3, 2022

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

May 31, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations