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The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure support ventilation, ARDSnet | Active Comparator | Mechanical ventilator is set to pressure support ventilation (6 ml/kg) for 30 min with positive end expiratory pressure (PEEP) set according to the "higher arm" of the ARDS network consensus. |
|
| Pressure control ventilation, ARDSnet | Active Comparator | Mechanical ventilator is set to pressure control ventilation (6 ml/kg) for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus. |
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| Neurally adjusted ventilatory assist, ARDSnet | Active Comparator | Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus. |
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| Neurally adjusted ventilatory assist, titrated | Active Comparator | Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation | Device | The mechanical ventilator is set to different ventilation modes as described in the individual arms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pressure-time product of the diaphragm | The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm. | average of last 15 minutes of each study arm |
| Patient - ventilator asynchrony index | Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm. | average of last 15 minutes of each study arm |
| Measure | Description | Time Frame |
|---|---|---|
| Transpulmonary pressure | Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm. | average of last 15 minutes of each study arm |
| Transdiaphragmatic pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leo Heunks, MD, PhD | Radboud University Nijmegen Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Nijmegen | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
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Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm. |
| average of last 15 minutes of each study arm |
| Oxygenation index | Oxygenation index is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen. Arterial oxygen tension is obtained at the end of each study arm. | at the end of each study arm |
| Dead space ventilation | Dead space ventilation is determined each breath using the Bohr equation: (PaCO2-PeCO2/PaCO2)*Vt. Here Vt is tidal volume, PaCO2 is the partial pressure of carbon dioxide in the arterial blood, and PeCO2 is the end-tidal carbon dioxide tension in the expired air. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm. | average of last 15 minutes of each study arm |
| D012138 |
| Respiratory Therapy |