Use of Neurally Adjusted Ventilatory Assist (NAVA) technology for invasively ventilated adults at risk of prolonged weaning from ventilatory support Respiratory
Conditions
Interventions
The study will compare NAVA Technology to conventional IMV. NAVA technology uses a specialised nasogastric/orogastric tube (NAVA catheter) to obtain the electrical activity of the diaphragm (EDi) musc
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or over 2. Receiving invasive mechanical ventilation 3. Expected to stay on invasive mechanical ventilation for = 48hrs 4. Any clinical risk factor for difficult or prolonged weaning from invasive ventilation
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 04/08/2025: 1. Death or treatment withdrawal imminent within 48 hours 2. Contraindication to nasogastric or orogastric tube insertion, such as upper airway or oesophageal trauma, bleeding or risk of bleeding due to recent surgery (e.g., oesophageal surgery), oesophageal varices and/or portal hypertension, and skull base fracture 3. A temporary or permanent cardiac pacemaker (potential impact on the EDi signal) 4. Phrenic nerve injury, Myasthenia Gravis or Guillain Barre Syndrome (potential impact on the EDi signal) 5. Severe central neurologic disorder causing elevated intracranial pressure, impaired control of breathing, or requiring neuroprotective ventilation (e.g. severe traumatic brain injury, refractory status epilepticus) 6. Known or suspected, severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence (e.g., Motor Neuron Disease, Duchenne Muscular Dystrophy, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, spinal cord injury above C6, Kyphoscoliosis, or other restrictive disorder). 7. Severe, end-stage, irreversible respiratory or cardiac disease with referral to a long-term weaning unit for likely chronic ventilator dependence, or referral to palliative care (e.g. severe irreversible pulmonary fibrosis or interstitial lung disease) 8. Home ventilation prior to ICU admission, excluding nocturnal CPAP 9. Previous participation in the UK NAVA trial. Previous exclusion criteria: 1. Death or treatment withdrawal imminent within 48 hours 2. Contraindication to NG or orogastric tube insertion, such as upper airway or oesophageal trauma, bleeding or risk of bleeding due to recent surgery, oesophageal varices or portal hypertension, and skull base fracture 3. An active cardiac pacemaker or phrenic nerve injury, due to their impact on the EDi signal. 4. Severe central neurologic disorder (e.g., traumatic brain injury, haemorrhage, stroke, tumour) causing elevated intracranial pressure, or impaired control of breathing, or requiring specific ventilator adjustments (i.e., to attain specific CO2 target) or requiring neurosurgical intervention 5. Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence (e.g., Motor Neuron Disease, Duchenne Muscular Dystrophy, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, high spinal cord injury, Kyphoscoliosis, or other restrictive disorder). 6. Severe, end-stage, irreversible respiratory or cardiac disease likely to result in chronic ventilator dependence (e.g. interstitial lung disease, pulmonary fibrosis, cardiomyopathy, valvulopathy) 7. Continuous therapeutic neuromuscular paralysis 8. Home ventilation prior to ICU admission, excluding nocturnal CPAP. 9. Previous participation in the UK NAVA trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation, measured by time from randomisation to first successful unassisted breathing or death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality, measured by survival at 2 and months 2. Time to first extubation, measured by time from randomisation to first successful extubation, up until ICU discharge 3. Reintubation, reintubation rates measured from randomisation up until ICU discharge 4. Use of Non-invasive ventilation, measured from randomisation up until ICU discharge 5. ICU and hospital length stay, measured by time from randomisation until ICU and hospital discharge 6. Serious adverse events, reportable from time of randomisation up until hospital discharge 7. Health-related Quality of Life and health care resource use, measured by EQ5D and resource use questionnaire at 2 and 6 months | — |
Countries
United Kingdom
Contacts
Public ContactMaddy Hill
Outcome results
None listed