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.
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.
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).
- Conditions
- Bronchioalveolar Lavage
- 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 group | Role | What they receive |
|---|---|---|
| Bronchoalveolar Lavage | Experimental | 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. Receives: Procedure: Bronchoalveolar Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted29 Jun 2016 (estimated)
- Study start6 Feb 2015
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Why it stopped: Not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchioalveolar LavageStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VIGNON Philippe, MD, Principal investigator, University Hospital, Limoges
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Effects of Bronchoalveolar Wash on Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02818049
- Acronym / sponsor ID
- FLOOD / I14033 FLOOD
- Conditions
- Bronchioalveolar Lavage
- Keywords
- Bronchioalveolar Lavage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patient
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoalveolar Lavage | Experimental | Procedure: Bronchoalveolar LavageBAL 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 LavageBAL 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. | Procedure or surgery | Bronchoalveolar Lavage |
Primary outcome
change in PaO2/FiO2 measurement
Time frame: Baseline and 10 minutes
Assessment of the change in PaO2/FiO2 in immediate post BAL compared to pre BAL results
Results and safety
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- 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.
VIGNON Philippe, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
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.