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Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients

Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03098888
Acronym
REA-LBA
Enrollment
483
Registered
2017-04-04
Start date
2017-04-03
Completion date
2019-04-03
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care, Lung Diseases

Keywords

side effects, decision making, indications, risk factors

Brief summary

Little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed. The primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.

Detailed description

Secondary objectives will be to * assess the frequency of poor quality bronchoalveolar lavages (as defined by either more than 5% bronchial epithelial cell count to less than 50,000 alveolar cells per mL) * assess the contribution of a given bronchoalveolar lavage to the diagnostic work up * assess the contribution of a given bronchoalveolar lavage results to therapeutic decision * assess the induced short term respiratory side effects * identify risk factors for poor respiratory tolerance

Interventions

PROCEDUREbronchoalveolar lavage

bronchoalveolar lavages performed for cytological assessment in critically ill patients with lung diseases, intubated or not

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patient (\> 18 yr-old) hospitalized in intensive care unit with acute and/or chronic lung disease that need bronchoalveolar lavage as part of routine diagnostic work up * patient's or family consent

Exclusion criteria

* consent not obtained * patient already included at previous bronchoalveolar lavage of during previous hospitalization * absence of social security number * age \< 18yr * pregnant woman

Design outcomes

Primary

MeasureTime frameDescription
quality of performed bronchoalveolar lavage72 hourspathologists examining bronchoalveolar lavage specimen will classify bronchoalveolar lavage as of poor quality or of good quality based upon cytologic assessment: bronchial cell count (not more than 5%) and alveolar cell count (above 50,000/mL).
contribution to diagnosis and/or therapeutic decision72 hoursInvestigators will be ask to answer the following question: Did the bronchoalveolar lavage results contribute to diagnosis and/or therapeutic decision: Yes or No
frequency of use72 hoursthe frequency of use of bronchoalveolar lavage will be describe and expressed as the proportion of patients who underwent bronchoalveoalr lavage upon the total number of patients admitted in the recruiting intensive care units during the study period

Secondary

MeasureTime frameDescription
Evolution of respiratory rate24 hoursrespiratory rate will be assessed before the bronchoalveolar lavage and 8 times during the 24 hours following the bronchoalveolar lavage
Evolution of oxygen needs24 hoursOxygen needs, in L/min in patients under conventional nasal or facial oxygen therapy, or expressed in FiO2 in patients under nasal high flow oxygen or under invasive or noninvasive ventilation, will be recorded before bronchoalveolar lavage and 8 times during the following 24 hours.
Need of tracheal intubation24 hoursPercentage of patients not intubated while undergoing bronchoalveolar lavage that will need intubation within 24 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026