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

NCT02818049 | Terminated

• 1 other identifier: I14033 FLOOD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Bronchioalveolar Lavage

Keywords

Bronchioalveolar Lavage

Outcome Measures

Primary Outcomes (1)

• change in PaO2/FiO2 measurement

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

  Baseline and 10 minutes

Study Arms (1)

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.

Procedure: Bronchoalveolar Lavage

Interventions

Bronchoalveolar Lavage PROCEDURE

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.

Bronchoalveolar Lavage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

Location

MeSH Terms

Interventions

Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• VIGNON Philippe, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 29, 2016
• Study Start: February 6, 2015
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)