- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818049
Cardiopulmonary Effects of Bronchoalveolar Wash on Patients With Acute Respiratory Distress Syndrome (FLOOD)
March 27, 2018 updated by: University Hospital, Limoges
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Limoges, France, 87042
- Limoges university hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bronchoalveolar Lavage
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in PaO2/FiO2 measurement
Time Frame: Baseline and 10 minutes
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Assessment of the change in PaO2/FiO2 in immediate post BAL compared to pre BAL results
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Baseline and 10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: VIGNON Philippe, MD, University Hospital, Limoges
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2015
Primary Completion (Actual)
February 6, 2018
Study Completion (Actual)
February 6, 2018
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2018
Last Update Submitted That Met QC Criteria
March 27, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- Dimercaprol
Other Study ID Numbers
- I14033 FLOOD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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