Neurally Adjusted Ventilatory Assist in Adults at Risk of Delayed Weaning From Mechanical Ventilation (RESTUS)
Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation
About this trial
This is an interventional supportive care trial for Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation focused on measuring Ventilator Weaning, Mechanical Ventilation, Critical Care, Neurally Adjusted Ventilatory Assist, Diaphragm
Eligibility Criteria
Inclusion Criteria:
ICU admissions who are likely to remain intubated and ventilated for greater than 48 hours with a diagnosis of one or a combination of:
- COPD
- Left and/or right ventricular heart failure
- Mild, moderate or severe (Berlin criteria) Acute Respiratory Distress Syndrome (ARDS)
All diagnoses must be documented in the medical notes. There must be evidence of a specialist consultant diagnosis, or a non-specialist doctor diagnosis with either objective test results (spirometry, CT, lung biopsy, cardiac echo) and/or prescribed treatment.
Exclusion Criteria:
- Less than 18 years old or pregnant
- Inability to conduct protocol (e.g. research staff or NAVA technology unavailable)
- No personal or nominated consultee available or assent declined
- Greater than 96 hours from intubation
- Greater than 24 hours in the weaning phase
- Patient likely to die/have treatment withdrawal within 48 hours
- Contraindication to passing NG tube
- Patients with primary neurological cause of ventilator dependence
- High spinal injury above C6; severe traumatic brain injury (Glasgow Coma Score < 8)
- Suspected or proven hypoxic brain injury
- Physician refusal / physician wishes to use NAVA
- Hepatic encephalopathy greater than grade one
- Domiciliary ventilation (except CPAP/BIPAP used for sleep disordered breathing)
- Enrollment in another interventional clinical trial in the last 30 days
- Non-English speakers where inadequate translation available to allow informed consent
Sites / Locations
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
NAVA technology
Standard Care
Following randomisation, a NAVA catheter will be introduced. The Electrical Activity of the Diaphragm (EAdi) will be viewed primarily to ensure a minimum level of diaphragm activation during the weaning phase. NAVA mode suitability/safety assessments will be conducted in all patients prior to the first initiation of the NAVA mode. The NAVA preview function on the Maquet Servo-i ventilators will be used to transfer from the previous mode to the NAVA mode, and the assessment will last for a maximum of 30 minutes. We are recommending the use of the NAVA ventilation mode during the weaning period. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.
A NAVA catheter will be inserted following randomisation. The NAVA capabilities of the ventilator will be disabled. Patients will be ventilated according to local weaning protocol as per current standard care with either Pressure Support, Synchronised Intermittent Mandatory Ventilation, Volume Controlled Ventilation, Pressure Controlled Ventilation or Pressure Regulated Volume Controlled Ventilation. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.