Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients

NCT ID: NCT03098888

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-04-03

Brief Summary

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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

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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

Conditions

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Lung Diseases Intensive Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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bronchoalveolar lavage

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toufik KAMEL, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans

Locations

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CHU d'ANGERS

Angers, , France

Site Status

CH d'ANGOULEME

Angoulême, , France

Site Status

CH Victor DUPOUY

Argenteuil, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

Hôpital RAYMOND POINCARE

Garches, , France

Site Status

CHD de VENDEE

La Roche-sur-Yon, , France

Site Status

CH de LA ROCHELLE

La Rochelle, , France

Site Status

Hopital de La Timone

Marseille, , France

Site Status

Hôpital Nord de Marseille

Marseille, , France

Site Status

CH de MONTAUBAN

Montauban, , France

Site Status

CHRU de NANTES

Nantes, , France

Site Status

CHR d'ORLEANS

Orléans, , France

Site Status

CHRU de POITIERS

Poitiers, , France

Site Status

CHU de STRASBOURG

Strasbourg, , France

Site Status

CHU de STRASBOURG NHC

Strasbourg, , France

Site Status

CHRU de TOURS

Tours, , France

Site Status

Countries

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France

Other Identifiers

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N° IDRCB 2017-A00306-47

Identifier Type: OTHER

Identifier Source: secondary_id

CHRO cat III 2017-01

Identifier Type: -

Identifier Source: org_study_id

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