moderate to severe Acute Respiratory Distress Syndrome and pulmonary inflammatory disease
Conditions
Interventions
Patients are mechanically ventilated with PCV mode at baseline. Upon inclusion
the EIT-belt and an esophageal balloon are placed to assess the EELV and
transpulmonary pressures respectively. Besides
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - 18 years or older; - Provided written informed consent; - Undergoing controlled mechanical ventilation via an endotracheal tube; - Meeting all criteria of the Berlin definition of ARDS: o Hypoxic respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms o Bilateral opacities on X-ray or CT-scan not fully explained by effusions, lobar/lung collapse (atelectasis), or nodules o Respiratory failure not fully explained by cardiac failure or fluid overload. o Oxygenation: moderate ARDS P/F ratio between 101-200 mmHg, severe ARDS PF ratio = 5 cmH2O. - Development of ARDS
Exclusion criteria
Exclusion criteria: - Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift) - Untreated pneumothorax (i.e. no pleural drainage) - Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose > 0.5mcrg/kg/min - High (>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure - An inner tube diameter of 6mm or less - Anticipating withdrawal of life support and/or shift to palliation as the goal of care - Inability to perform adequate electrical impedance tomography (EIT) measurements - Contra-indications for nasogastric tube or inability to perform adequate transpulmonary pressure measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the difference in Mechanical Power (Joules per minute) after 90 minutes on FCV compared to after 90 minutes of PCV; obtained from the Pressure-Volume loops. | — |
Secondary
| Measure | Time frame |
|---|---|
| These following secondary study parameters will be measured at baseline (PCV) and thereafter every 30 minutes on FCV and PCV for a total of 180 minutes: - Dissipated energy (Joules per tidal volume) derived from Pressure-Volume Loops - EELV assessed by EIT; an important secondary endpoint is the difference in EELV after 30 minutes on FCV compared to after 30 minutes on PCV. - Airway pressures (peak airway pressure, plateau pressure, mean airway pressure, PEEP, intrinsic PEEP, driving pressure) as measured on the airway pressure tracings - Transpulmonary pressures (end-expiratory transpulmonary pressure, end-inspiratory transpulmonary pressure, transpulmonary driving pressure) as measured using esophageal manometry - Minute volume as measured using flow tracings - Ventilatory ratio as a measure of dead space ventilation - Regional Ventilatory Delay Index (RVDI) assessed by EIT - Global Inhomogenity Index (GI) assessed by EIT - P/F ratio - Hemodynamic parameters (e.g. mean arterial pressure, heart rate) These following secondary study parameters will be measured at five points during the study, namely at baseline (PCV), two times after a 90 minutes ventilation study period (FCV/PCV) and 90 minutes and 24 hours after the end of the study (PCV). Biomarkers in EBC (exhaled breath condensate) as a measurement for pulmonary inflammation that will be measured are pro-inflammatory cytokines IL-1β, IL-6, IL-12p70, TNF-a, anti-inflammatory cytokine IL-10 and chemokine IL-8 and biomarkers CD14, CD163 and CD25 for monocyt, macrophage and T-cell activation respectively. | — |
Countries
Netherlands
Outcome results
None listed