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Bronchioalveolar LavageFLOODNCT02818049

Cardiopulmonary Effects of Bronchoalveolar Wash on Patients With Acute Respiratory Distress Syndrome

A study testing Bronchoalveolar Lavage in people with Bronchioalveolar Lavage, run by University Hospital, Limoges at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by an inflammatory pulmonary edema, severe hypoxia and endothelial and epithelial diffuse aggression. A European study estimated that this disease represents 7% of admissions to intensive care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchioalveolar Lavage
What is being tested?
Bronchoalveolar Lavage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteFrance
Study dates
6 Feb 2015to 6 Feb 2018
Phase
Interventional
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

Who may be able to join

  • Patients older than 18 years
  • Patients intubated mechanically ventilated
  • Patients with ARDS according to the new definition of Berlin
  • Patients under sedation / analgesia
  • Patients for whom BAL is programmed
  • Collection of non-family opposition

Who cannot join

  • PaO2 / FiO2 <50 or any situation which according to investigator would create a risk to the patient during the procedure
  • Persistent hypotension despite the administered therapeutic
  • Patients tracheotomy
  • Patients dying
  • Care limitations Patients
  • Known allergy to muscle relaxants
  • Pregnant woman
  • Patients under guardianship or under judicial protection

Trial locations and contacts

1 site in 1 country.

France1 site
  • Limoges University Hospital

    Limoges, 87042

Other trials in France

About this study

The acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by an inflammatory pulmonary edema, severe hypoxia and endothelial and epithelial diffuse aggression. A European study estimated that this disease represents 7% of admissions to intensive care. Despite progress on the modalities of mechanical ventilation, mortality is always between 25 and 55%. The definition of this syndrome was recently amended by individualizing three sub groups based on the importance of hypoxemia (mild, moderate and severe). Achieving a bronchoalveolar lavage (BAL) by bronchoscopy remains a gold standard in the initial research of pulmonary infectious cause or secondarily face the suspicion of ventilator-associated pneumonia. Cardio pulmonary consequences of this act are not well known in patients with ARDS. The first studies on the consequences of a bronchoscopy on oxygenation of a patient breathing spontaneously have 40 years. More recent work showed a simple bronchoscopy could in the mechanically ventilated patient cause an average decrease of 26% from the base of PaO2, 10% of the mean arterial pressure (MAP) and a significant increase in cardiac output. The existence of ARDS was an independent risk factor associated with hypoxemia. A study by published in Crit Care Med in 1990 can serve as a reference in ventilated patients benefiting from BAL by bronchoscopy: in a subgroup of 26 patients, 23% of patients required an increase in the fraction of inspired oxygen (FiO2) post procedure. A study compared changes in PaO2/FiO2 after BAL with and without endoscopy among patients without (n = 23) or with pneumonia (n = 11): the decrease in PaO2/FiO2 was significant only in the "pneumonia" group. In a study of 30 patients ventilated but not hypoxic , PaO2 was still reduced by 20% 2 hours after the completion of a BAL in 40% of patients. A retrospective series of 99 ventilated patients but not hypoxic, shows that the BAL was well tolerated in accordance with a pre oxygenation procedure 15 min and by gradually decreasing the FiO 2 after the end of the procedure. BAL also appears well tolerated in a study of 12 patients ventilated under sedation and muscle relaxation, in shock and in need of positive expiratory pressure (PEEP) of at least 10 cm H2O but the authors show a decrease in PaO2 that extends well beyond the end of the intervention. Their conclusion is going to offer less invasive diagnostic techniques for patients with PaO2 less than 60 mm. No study has targeted the respiratory and hemodynamic consequences of this technique depending on the intensity of ARDS (mild, moderate or severe).

Being tested
Bronchoalveolar Lavage
Keywords
Bronchioalveolar Lavage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bronchoalveolar LavageProcedure or surgery

    BAL was performed in accordance with current practice. Patients are oxygenated with FiO2=1 at least 5 min before the start and 4 h after the procedure. Blood pressure, central venous pressure, heart rate and breathing are monitored by a monitor. O2 saturation (SpO2) is monitored continuously by pulse oximetry.

Study groups in NCT02818049
Study groupRoleWhat they receive
Bronchoalveolar LavageExperimentalBAL was performed in accordance with current practice. Patients are oxygenated with FiO2=1 at least 5 min before the start and 4 h after the procedure. Blood pressure, central venous pressure, heart rate and breathing are monitored by a monitor. O2 saturation (SpO2) is monitored continuously by pulse oximetry.
Receives: Procedure: Bronchoalveolar Lavage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in PaO2/FiO2 measurement

    Assessment of the change in PaO2/FiO2 in immediate post BAL compared to pre BAL results

    Measured: Baseline and 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start6 Feb 2015
  3. Primary completion6 Feb 2018
  4. Study completion6 Feb 2018

Why it stopped: Not enough patient

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818049
Sponsor's protocol ID
I14033 FLOOD
Acronym
FLOOD
Status last verified
Mar 2018
First submitted
15 Jun 2016
Last updated
29 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bronchoalveolar Lavage in people with Bronchioalveolar Lavage, run by University Hospital, Limoges at 1 site 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Not enough patient). Results are not available in the source record.

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?

change in PaO2/FiO2 measurement (time frame: Baseline and 10 minutes). 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 29 Mar 2018.

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