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The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung collapse and overdistention crossing point PEEP | Experimental |
| |
| Low lung collapse PEEP | Experimental |
| |
| Low lung overdistention PEEP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in PEEP | Other | Patients will undergo a decremental PEEP trial to determine the crossing-point PEEP. Secondly, three PEEP levels (low collapse PEEP, low overdistention PEEP and crossing point between lung collapse and overdistention PEEP) will be compared in a randomized order with 30-minute steps |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of lung collapse on cardiac output | Evaluation of the relative contribution of lung collapse (arbitrary units) on patients' cardiac output at different PEEP levels (L/min) | Assesment performed at the end of each of the three 30 minute steps |
| Impact of lung collapse on pulmonary vascular resistance | Evaluation of the relative contribution of lung collapse (arbitrary units) on pulmonary vascular resistance (dyn·s/cm^5) at different PEEP levels | Assesment performed at the end of each of the three 30 minute steps |
| Impact of lung overdistention on cardiac output | Evaluation of the relative contribution of lung overdistention (arbitrary units) on patients' cardiac output at different PEEP levels (L/min) | Assesment performed at the end of each of the three 30 minute steps |
| Impact of lung overdistention on pulmonary vascular resistance | Evaluation of the relative contribution of lung overdistention (arbitrary units) on pulmonary vascular resistance (dyn·s/cm^5) at different PEEP levels | Assesment performed at the end of each of the three 30 minute steps |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between potential for lung recruitment and PEEP-induced changes in cardiac output | The effects of PEEP on cardiac output (mL/min) will be correlated through Pearson correlations with the individual potential for lung recruitment, as determined by the recruitment-to-inflation ratio (R/I) | Assessment at the end of each of the three 30 minute steps |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico Luca Grieco, MD | Contact | +393397681623 | dlgrieco@outlook.it |
| Name | Affiliation | Role |
|---|---|---|
| Domenico Luca Grieco, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A.Gemelli IRCCS | Rome | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D003244 | Consciousness Disorders |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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Randomized crossover trial
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|
| Correlation between potential for lung recruitment and PEEP-induced changes in pulmonary vascular resistance | The effects of PEEP on pulmonary vascular resistance (dyn·s/cm^5) will be correlated through Pearson correlations with the individual potential for lung recruitment, as determined by the recruitment-to-inflation ratio (R/I) | Assesment performed at the end of each of the three 30 minute steps |
| PEEP-induced effects on cardiac output in cardiac preload responsive vs. nonresponsive patients | The effects of PEEP on cardiac output (L/min) will be compared through subgroup comparisons (student t-test) in patients who are preload responsive and patients who are not (preload responsiveness assessed through pulse-pressure variation, expressed in %) | Assesment performed at the end of each of the three 30 minute steps |
| PEEP-induced effects on pulmonary vascular resistance in cardiac preload responsive vs. nonresponsive patients | The effects of PEEP on pulmonary vascular resistance (dyn·s/cm^5) will be compared through subgroup comparisons (student t-test) in patients who are preload responsive and patients who are not (preload resposnsiveness assessed through pulse-pressure variation, expressed in %) | Assesment performed at the end of each of the three 30 minute steps |
| Relationship between transpulmonary pressures and central venous pressure variations | The relationship between transpulmonary pressure variations (cmH2O) and central venous pressure variations (cmH2O) between PEEP levels will be assessed through Pearson correlations | At the end of each of the three 30 minute steps |
| Lung hysteresis | Lung hysteresis will be assessed at each of the tested PEEP levels and expressed as the area of the pressure-volume loop of the respiratory system obtained with a low-flow inflation/deflation maneuver from PEEP to a pressure of 30 cmH2O, in mL*cmH2O | At the end of each of the three 30 minute steps |
| Lung aeration distribution | Lung aeration distribution at each PEEP level tested will be assessed with electrical impedance tomography (EIT) and expressed as dorsal fraction of ventilation (% of total tidal volume) | At the end of each of the three 30 minute steps |
| Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in pulmonary vascular resistance | The effects of PEEP on pulmonary vascular resistance (dyn·s/cm^5) will be correlated through Pearson correlations with the individual PEEP-induced changes in lung volume (mL) | Assesment performed at the end of each of the three 30 minute steps |
| Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in cardiac output | The effects of PEEP cardiac output (L/min) will be correlated through Pearson correlations with the individual PEEP-induced changes in lung volume (mL) | Assesment performed at the end of each of the three 30 minute steps |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |