Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients (REA-LBA)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Intensive Care
• Intervention / Treatment: Procedure: bronchoalveolar lavage

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

• Study Type: Observational
• Enrollment (Actual): 483

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU d'Angers
  • Angoulême, France
    • CH D'Angouleme
  • Argenteuil, France
    • CH Victor Dupouy
  • Dijon, France
    • CHU de Dijon
  • Garches, France
    • Hôpital Raymond Poincaré
  • La Roche sur Yon, France, 85925
    • CHD de Vendée
  • La Rochelle, France, 17019
    • CH de la Rochelle
  • Marseille, France
    • Hôpital de la Timone
  • Marseille, France
    • Hopital Nord de Marseille
  • Montauban, France
    • CH de Montauban
  • Nantes, France, 44093
    • CHRU de Nantes
  • Orléans, France
    • CHR d'Orléans
  • Poitiers, France, 86021
    • CHRU de POITIERS
  • Strasbourg, France, 67000
    • CHU de Strasbourg
  • Strasbourg, France
    • CHU de STRASBOURG NHC
  • Tours, France, 37044
    • CHRU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Need of tracheal intubation	Percentage of patients not intubated while undergoing bronchoalveolar lavage that will need intubation within 24 hours	24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Toufik KAMEL, MD, CHR Orléans

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: risk factors; decision making; side effects; indications
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: CHRO cat III 2017-01; N° IDRCB 2017-A00306-47 (Other Identifier: French Government)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No