ARDS
Conditions
Keywords
Mechanical Ventilation
Brief summary
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Another strategy of invasive ventilation, Time-Controlled Adaptative Ventilation (TCAV), is the application of specific settings to the airway pressure release ventilation (APRV) mode. TCAV is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. In prospective and retrospective clinical reviews, as well as in experimental animal studies, TCAV has demonstrated improvements in oxygenation and lung function, with the ability to prevent ARDS. The thoracic computed tomography (CT) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation). The objective of this study is to evaluate, with CT scans performed to assess lungs of patients with ARDS, the effects of TCAV compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension.
Interventions
OTHERTime-controlled adaptative ventilation (TCAV)
Ventilation with TCAV set on the APRV mode on the ventilator.
Ventilation with the VCV mode set on the ventilator.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ARDS according to the Berlin definition * invasive ventilation for no longer than 72 hours * patient requiring a diagnostic thoracic CT scan * consent of a family member or the person of trust * social security affiliation
Exclusion criteria
* Use of iodinated contrast media injection before CT acquisitions * ARDS criteria present during 72 hours or more * Severe COPD * Pneumothorax or other barotrauma-related complication * Right ventricular failure other than acute cor pulmonale * Absence of sedative agents and neuromuscular blockade * Severe hemodynamic instability (norepinephrine \> 0.5 µg/kg/min) * VA-ECMO assistance * Pregnancy * Absence of the capacity to give consent before admission to the ICU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of end-expiratory non aerated lung parenchyma | during procedure (10 minutes) | Percentage of non aerated lung parenchyma defined as % of lung at -100 to +100 Hounsfield Units (HU) divided by total lung weight, at the end of expiration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End-inspiratory overdistention in TCAV | 10 minutes | Percentage of hyper-aerated lung parenchyma defined as lung volume at ≤ - 901 Hounsfield Units (HU) divided by total lung volume, at the end of inspiration in TCAV. |
| Tidal hyperinflation in TCAV | 10 minutes | Tidal hyperinflation is defined as the volume of the hyper-aerated (density ≤ - 901 HU) compartment at end-inspiration minus hyper-aerated (density ≤ - 901 HU) volume at end-expiration, and standardized to predicted body weight (PBW), expressed in ml/kg of PBW |
| Atelectrauma in TCAV and VCV | 10 minutes | Tidal recruitment of the non-aerated (-100 to +100 Hounsfield Units) compartment was defined as the weight of the non-aerated compartment at end-expiration minus its weight at end-inspiration, and standardized to total lung weight, expressed in %. |
| Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV | 10 minutes | Area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation |
| Correlation between driving pressure and tidal hyperinflation in TCAV | 10 minutes | Area under ROC curve of driving pressure to detect cyclic hyperinflation |
Countries
France
Contacts
Primary ContactBenjamin Pequignot, MD
Backup ContactMatthieu Koszutski, MD
Outcome results
None listed