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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098888
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

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.


Condition or disease Intervention/treatment
Lung Diseases Intensive Care 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

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Study Type : Observational
Actual Enrollment : 483 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

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


Primary Outcome Measures :
  1. quality of performed bronchoalveolar lavage [ Time Frame: 72 hours ]
    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).

  2. contribution to diagnosis and/or therapeutic decision [ Time Frame: 72 hours ]
    Investigators will be ask to answer the following question: Did the bronchoalveolar lavage results contribute to diagnosis and/or therapeutic decision: Yes or No

  3. frequency of use [ Time Frame: 72 hours ]
    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


Secondary Outcome Measures :
  1. Evolution of respiratory rate [ Time Frame: 24 hours ]
    respiratory rate will be assessed before the bronchoalveolar lavage and 8 times during the 24 hours following the bronchoalveolar lavage

  2. Evolution of oxygen needs [ Time Frame: 24 hours ]
    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.

  3. Need of tracheal intubation [ Time Frame: 24 hours ]
    Percentage of patients not intubated while undergoing bronchoalveolar lavage that will need intubation within 24 hours



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098888


Locations
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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, 85925
CH de LA ROCHELLE
La Rochelle, France, 17019
Hopital de La Timone
Marseille, France
Hôpital Nord de Marseille
Marseille, France
CH de MONTAUBAN
Montauban, France
CHRU de NANTES
Nantes, France, 44093
CHR d'ORLEANS
Orléans, France
CHRU de POITIERS
Poitiers, France, 86021
CHU de STRASBOURG
Strasbourg, France, 67000
CHU de STRASBOURG NHC
Strasbourg, France
CHRU de TOURS
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Toufik KAMEL, MD CHR Orléans
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03098888    
Other Study ID Numbers: CHRO cat III 2017-01
N° IDRCB 2017-A00306-47 ( Other Identifier: French Government )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
side effects
decision making
indications
risk factors
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases