Status:
COMPLETED
Neurally Adjusted Ventilatory Assist in Adults at Risk of Delayed Weaning From Mechanical Ventilation
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
King's College London
Conditions:
Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Many patients admitted to intensive care have heart or lung problems. Patients with these conditions often require longer durations of support from breathing machines. Survival and long-term recovery ...
Detailed Description
In this study, we will compare the use of Neurally Adjusted Ventilatory Assist technology (the NAVA ventilation mode and the monitoring capabilities) against standard care in patients who are at risk ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01826890
Start Date
May 1 2013
End Date
March 1 2018
Last Update
March 25 2019
Active Locations (1)
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1
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS