Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients

Lung Diseases Clinical Trial

— REA-LBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098888
• Other study ID #: CHRO cat III 2017-01
• Secondary ID: N° IDRCB 2017-A0
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: April 3, 2019

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHU d'ANGERS	Angers
France	CH d'ANGOULEME	Angoulême
France	CH Victor DUPOUY	Argenteuil
France	CHU de DIJON	Dijon
France	Hôpital RAYMOND POINCARE	Garches
France	CHD de VENDEE	La Roche sur Yon
France	CH de LA ROCHELLE	La Rochelle
France	Hopital de La Timone	Marseille
France	Hôpital Nord de Marseille	Marseille
France	CH de MONTAUBAN	Montauban
France	CHRU de NANTES	Nantes
France	CHR d'ORLEANS	Orléans
France	CHRU de POITIERS	Poitiers
France	CHU de STRASBOURG	Strasbourg
France	CHU de STRASBOURG NHC	Strasbourg
France	CHRU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of performed bronchoalveolar lavage	pathologists 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).	72 hours
Primary	contribution to diagnosis and/or therapeutic decision	Investigators will be ask to answer the following question: Did the bronchoalveolar lavage results contribute to diagnosis and/or therapeutic decision: Yes or No	72 hours
Primary	frequency of use	the 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	72 hours
Secondary	Evolution of respiratory rate	respiratory rate will be assessed before the bronchoalveolar lavage and 8 times during the 24 hours following the bronchoalveolar lavage	24 hours
Secondary	Evolution of oxygen needs	Oxygen 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.	24 hours
Secondary	Need of tracheal intubation	Percentage of patients not intubated while undergoing bronchoalveolar lavage that will need intubation within 24 hours	24 hours