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Completed

NCT Number: NCT03098888

Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients

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.

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Key information

Conditions

Lung Diseases Intensive Care Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'ANGERS, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoalveolar lavage

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: REA-LBA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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