ArticlesEarly use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial
Introduction
Prospective randomised controlled trials of non-invasive ventilation (NIV) within the intensive-care unit (ICU) have shown reductions in the need for intubation and in-hospital mortality associated with severe exacerbations of chronic obstructive pulmonary disease (COPD).1, 2, 3 The evidence from randomised controlled trials within the accident and emergency department and general respiratory ward is mixed.4, 5, 6, 7 Bott and colleagues, using research staff to initiate ventilation on the ward, showed that NIV improved pH and PaCO2.4 On an intention-to-treat analysis there was no survival benefit from NIV, until those unable to tolerate NIV were excluded. The use of research staff makes it difficult to generalise the results of this study to routine clinical practice. Angus and colleagues randomised 17 patients to either NIV (n=9) or conventional therapy plus doxapram (n=8). There was a non-significant trend to improved survival in the NIV group with three out of eight patients dying with conventional care and nine out of nine surviving with NIV.5 Barbe and colleagues found NIV unnecessary because none of the 24 patients in their study died or required intubation.6 Wood and colleagues found that NIV delayed intubation and increased in-hospital mortality.7 However, of the 27 patients in this study only six had COPD, the groups were not well matched, and the level of pressure support was modest.
The use of NIV in general respiratory wards could theoretically allow the earlier use of NIV during an exacerbation and widen the availability of NIV. This is particularly important in the UK where there is a shortage of ICU and high-dependency bed provision.
We therefore aimed to find out whether NIV was feasible on the ward in non-specialist units and whether it was effective at reducing the need for intubation and in-hospital mortality, compared with standard treatment, in patients admitted with mild-to-moderate acidosis due to an exacerbation of COPD. Patients with acidosis are at higher risk of subsequent intubation and death than patients with a normal pH.8, 9 The null hypothesis was that NIV on the ward would not reduce the need for intubation in this clinical group.8
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Patients
Between November, 1996, and September, 1998, adult patients who were in hospital because of an acute exacerbation of COPD were prospectively recruited from 14 hospitals in the UK: Airedale District Hospital, Birch Hill Hospital (Rochdale), Bradford Royal Infirmary, Castle Hill Hospital (Hull), Churchill Hospital (Oxford), Dewsbury and District Hospital, Doncaster Royal Infirmary, Halifax General Hospital, Huddersfield Royal Infirmary, Killingbeck Hospital (Leeds), Leeds General Infirmary,
Characteristics of patients
118 patients were randomly assigned to standard treatment and 118 to NIV (figure 1). The two groups had similar characteristics on admission (table 1). The use of aminophylline and doxapram was not different between the two groups.
Setting
In each hospital between one and three general medical/respiratory wards were identified as sites for NIV. Of the 25 wards involved in the trial, 22 had no experience of NIV and only one was fully experienced. None had previously used the study ventilator. In none of
Discussion
This study shows that the use of NIV on general respiratory wards is both feasible and clinically effective at reducing the demand for invasive ventilatory support and the in-hospital mortality associated with acute ventilatory failure in patients with a clinical diagnosis of COPD.
NIV could be established (defined as > 1 h of use) in 93% of patients, similar to the 87% described by Bott and colleagues,4 and only consumed an additional 26 min of nursing time. In a low nurse-to-patient setting
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