NCT03098888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

March 23, 2017

Last Update Submit

May 22, 2019

Conditions

Lung DiseasesIntensive Care

Keywords

side effectsdecision makingindicationsrisk factors

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Evolution of respiratory rate

    24 hours

  • Evolution of oxygen needs

    24 hours

  • Need of tracheal intubation

    24 hours

Interventions

bronchoalveolar lavagePROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • consent not obtained
  • patient already included at previous bronchoalveolar lavage of during previous hospitalization
  • absence of social security number
  • age \< 18yr
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

CHU d'ANGERS

Angers, France

Location

CH d'ANGOULEME

Angoulême, France

Location

CH Victor DUPOUY

Argenteuil, France

Location

CHU de DIJON

Dijon, France

Location

Hôpital RAYMOND POINCARE

Garches, France

Location

CHD de VENDEE

La Roche-sur-Yon, 85925, France

Location

CH de LA ROCHELLE

La Rochelle, 17019, France

Location

Hopital de La Timone

Marseille, France

Location

Hôpital Nord de Marseille

Marseille, France

Location

CH de MONTAUBAN

Montauban, France

Location

CHRU de NANTES

Nantes, 44093, France

Location

CHR d'ORLEANS

Orléans, France

Location

CHRU de POITIERS

Poitiers, 86021, France

Location

CHU de STRASBOURG

Strasbourg, 67000, France

Location

CHU de STRASBOURG NHC

Strasbourg, France

Location

CHRU de TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Toufik KAMEL, MD

    CHR Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 4, 2017

Study Start

April 3, 2017

Primary Completion

April 3, 2019

Study Completion

April 3, 2019

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(16)