The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Pressure-time product of the diaphragm
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •intubated, mechanically ventilated patients
- •meeting criteria for ARDS
- •mean arterial blood pressure > 65 mmHg (with or w/o vasopressors)
Exclusion Criteria
- •pregnancy
- •increased intracranial pressure
- •contra-indication naso-gastric tube
- •diagnosed neuro-muscular disorder
- •recent (<12 hours) use of muscle relaxants
- •exclusion from sedation interruption protocol as used in our institution
- •open chest or- abdomen
- •very high inspiratory flow rate during supported ventilation
- •inability to obtain informed consent
Outcomes
Primary Outcomes
Pressure-time product of the diaphragm
Time Frame: average of last 15 minutes of each study arm
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.
Patient - ventilator asynchrony index
Time Frame: average of last 15 minutes of each study arm
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.
Secondary Outcomes
- Transpulmonary pressure(average of last 15 minutes of each study arm)
- Transdiaphragmatic pressure(average of last 15 minutes of each study arm)
- Oxygenation index(at the end of each study arm)
- Dead space ventilation(average of last 15 minutes of each study arm)
Investigators
Leo Heunks
MD PhD
University Medical Center Nijmegen