Lung DiseasesREA-LBANCT03098888
Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients
An observational study of Lung Diseases and Intensive Care, run by Centre Hospitalier Régional d'Orléans at 16 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Intensive Care
- What is being tested?
- bronchoalveolar lavage
- Type of treatment
- Surgery or procedure
- How many people
- 483 participants
- Where
- 16 sitesFrance
- Study dates
- 3 Apr 2017to 3 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- consent not obtained
- patient already included at previous bronchoalveolar lavage of during previous hospitalization
- absence of social security number
- age < 18yr
- pregnant woman
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CHU d'ANGERS
Angers
CH d'ANGOULEME
Angoulême
CH Victor DUPOUY
Argenteuil
CHU de DIJON
Dijon
Hôpital RAYMOND POINCARE
Garches
CHD de VENDEE
La Roche-sur-Yon, 85925
CH de LA ROCHELLE
La Rochelle, 17019
Hopital de La Timone
Marseille
Hôpital Nord de Marseille
Marseille
CH de MONTAUBAN
Montauban
CHRU de NANTES
Nantes, 44093
CHR d'ORLEANS
Orléans
CHRU de POITIERS
Poitiers, 86021
CHU de STRASBOURG
Strasbourg, 67000
CHU de STRASBOURG NHC
Strasbourg
CHRU de TOURS
Tours, 37044
About this study
Official title: 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.
Read the 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
- Conditions
- Lung Diseases, Intensive Care
- Being tested
- bronchoalveolar lavage
- Keywords
- side effects, decision making, indications, risk factors
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoalveolar lavageProcedure or surgery
bronchoalveolar lavages performed for cytological assessment in critically ill patients with lung diseases, intubated or not
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 72 hours
Secondary outcomes (3)
Evolution of respiratory rate
respiratory rate will be assessed before the bronchoalveolar lavage and 8 times during the 24 hours following the bronchoalveolar lavage
Measured: 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.
Measured: 24 hours
Need of tracheal intubation
Percentage of patients not intubated while undergoing bronchoalveolar lavage that will need intubation within 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start3 Apr 2017
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toufik KAMEL, MD, Principal investigator, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098888
- Sponsor's protocol ID
- CHRO cat III 2017-01
- Other IDs
- N° IDRCB 2017-A00306-47
- Acronym
- REA-LBA
- Status last verified
- May 2019
- First submitted
- 23 Mar 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03098888
- Acronym / sponsor ID
- REA-LBA / CHRO cat III 2017-01
- Conditions
- Lung Diseases, Intensive Care
- Keywords
- side effects, decision making, indications, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- consent not obtained
- patient already included at previous bronchoalveolar lavage of during previous hospitalization
- absence of social security number
- age < 18yr
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoalveolar lavagebronchoalveolar lavages performed for cytological assessment in critically ill patients with lung diseases, intubated or not | Procedure or surgery | – |
Primary outcome
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).
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
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
3 secondary outcomes
Evolution of respiratory rate
Time frame: 24 hours
Evolution of oxygen needs
Time frame: 24 hours
Need of tracheal intubation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toufik KAMEL, MD principal investigator
CHR Orléans
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Intensive Care, run by Centre Hospitalier Régional d'Orléans at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of performed bronchoalveolar lavage (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.