Non-Invasive Ventilation Outcomes score-directed Weaning (NIVOW) v1.0
Research type
Research Study
Full title
Standard versus accelerated weaning from non-invasive ventilation (NIV) in chronic obstructive pulmonary disease directed by the NIV Outcomes score: a randomised controlled trial.
IRAS ID
313485
Contact name
Stephen Bourke
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
ISRCTN Number
ISRCTN64639614
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Why do this research?
Every year in the UK, over 141,000 people are admitted into hospital due to Exacerbations of Chronic Obstructive Pulmonary Disease (ECOPD). One-quarter of these patients develop life-threatening respiratory failure, with a build-up of carbon dioxide (waste gas).
Non-invasive ventilation (NIV) involves wearing a tightly-fitted mask connected to a ventilator, to help patients breathe out more carbon dioxide. NIV halves the risk of dying, but can cause unpleasant side effects.
Once patients are improving, NIV is gradually ‘weaned’ over 3-4 days. Faster weaning should reduce side-effects and costs. However shorter treatment may be less effective, and carbon dioxide build-up may recur.
There are big differences in weaning time and relapse rates nationally, with little evidence to guide practice.
Our recently developed NIV Outcomes Score predicts risk of death in NIV-treated patients. Three in four patients have low or medium risk, and may benefit from faster weaning. COPD patients needing NIV strongly support this research.Our aim.
To investigate whether patients with ECOPD requiring NIV can be safely weaned more quickly.How will we do it?
Patients hospitalised with ECOPD requiring NIV will be recruited over 24 months, randomised to a ‘standard’ or ‘accelerated’ wean and followed for 90 days. The accelerated wean involves a daily 4-hour trial without NIV, under close monitoring.
If carbon dioxide levels in the blood are stable and safe, NIV will be stopped early. To ensure our results apply across the NHS, we will include several hospitals serving diverse populations.
Patient outcomes, including NIV weaning time and death, will be captured. We will also assess: side-effects from NIV, relapse, sleep quality, symptoms, quality of life, hospital readmissions, and costs.Sharing results.
Results will be shared with participants and national organisations (reaching people with COPD), presented at conferences, and published in medical journals.REC name
West of Scotland REC 1
REC reference
22/WS/0091
Date of REC Opinion
8 Sep 2022
REC opinion
Further Information Favourable Opinion