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

Primary Purpose

Bronchioalveolar Lavage

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bronchoalveolar Lavage
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchioalveolar Lavage focused on measuring Bronchioalveolar Lavage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Limoges University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchoalveolar Lavage

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 15, 2016
Last Updated
March 27, 2018
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02818049
Brief Title
Cardiopulmonary Effects of Bronchoalveolar Wash on Patients With Acute Respiratory Distress Syndrome
Acronym
FLOOD
Official Title
Cardiopulmonary Effects of Bronchoalveolar Wash on Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Not enough patient
Study Start Date
February 6, 2015 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchioalveolar Lavage
Keywords
Bronchioalveolar Lavage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchoalveolar Lavage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bronchoalveolar Lavage
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in PaO2/FiO2 measurement
Description
Assessment of the change in PaO2/FiO2 in immediate post BAL compared to pre BAL results
Time Frame
Baseline and 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VIGNON Philippe, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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