Clinical trial NCT03098888: Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients
Official title: Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Intensive Care
Keywords: side effects
decision making
indications
risk factors
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients hospitalized in intensive care unit with acute and/or chronic lung disease that need bronchoalveolar lavage as part of the diagnostic work up

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

Eligibility criteria: 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

Primary outcomes:
measure: quality of performed bronchoalveolar lavage
timeFrame: 72 hours
measure: contribution to diagnosis and/or therapeutic decision
timeFrame: 72 hours
measure: frequency of use
timeFrame: 72 hours
Secondary outcomes:
measure: Evolution of respiratory rate
timeFrame: 24 hours
measure: Evolution of oxygen needs
timeFrame: 24 hours
measure: Need of tracheal intubation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'ANGERS
city: Angoulême
country: France
facility: CH d'ANGOULEME
city: Argenteuil
country: France
facility: CH Victor DUPOUY
city: Dijon
country: France
facility: CHU de DIJON
city: Garches
country: France
facility: Hôpital RAYMOND POINCARE
city: La Roche sur Yon
country: France
facility: CHD de VENDEE
city: La Rochelle
country: France
facility: CH de LA ROCHELLE
city: Marseille
country: France
facility: Hopital de La Timone
city: Marseille
country: France
facility: Hôpital Nord de Marseille
city: Montauban
country: France
facility: CH de MONTAUBAN
city: Nantes
country: France
facility: CHRU de NANTES
city: Orléans
country: France
facility: CHR d'ORLEANS
city: Poitiers
country: France
facility: CHRU de POITIERS
city: Strasbourg
country: France
facility: CHU de STRASBOURG
city: Strasbourg
country: France
facility: CHU de STRASBOURG NHC
city: Tours
country: France
facility: CHRU de TOURS
Study officials:
affiliation: CHR Orléans
name: Toufik KAMEL, MD
role: PRINCIPAL_INVESTIGATOR
References: