Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial

Abstract

Background: Sleep hypoventilation has been proposed as a cause of progressive hypercapnic respiratory failure and death in patients with severe chronic obstructive pulmonary disease (COPD). A study was undertaken to determine the effects of nocturnal non-invasive bi-level pressure support ventilation (NIV) on survival, lung function and quality of life in patients with severe hypercapnic COPD. Method: A multicentre, open-label, randomised controlled trial of NIV plus long-term oxygen therapy (LTOT) versus LTOT alone was performed in four Australian University Hospital sleep/respiratory medicine departments in patients with severe stable smoking-related COPD (forced expiratory volume in 1 s (FEV 1.0 ) ,1.5 litres or ,50% predicted and ratio of FEV 1.0 to forced vital capacity (FVC) ,60% with awake arterial carbon dioxide tension (PaCO 2 ) .46 mm Hg and on LTOT for at least 3 months) and age ,80 years. Patients with sleep apnoea (apnoea-hypopnoea index .20/h) or morbid obesity (body mass index .40) were excluded. Outcome measures were survival, spirometry, arterial blood gases, polysomnography, general and disease-specific quality of life and mood. Results: 144 patients were randomised (72 to NIV + LTOT and 72 to LTOT alone). NIV improved sleep quality and sleep-related hypercapnia acutely, and patients complied well with therapy (mean (SD) nightly use 4.5 (3.2) h). Compared with LTOT alone, NIV (mean follow-up 2.21 years, range 0.01-5.59) showed an improvement in survival with the adjusted but not the unadjusted Cox model (adjusted hazard ratio (HR) 0.63, 95% CI 0.40 to 0.99, p = 0.045; unadjusted HR 0.82, 95% CI 0.53 to 1.25, p = NS). FEV

Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation

“…31,32 The unblinded trial design and lack of a sham device, with blinded assessment in terms of the outcome, is consistent with other clinical trials in this field. 11,12,14,15 Second, the trial design was pragmatic in that it made provision for patients initially allocated to home oxygen therapy to have home noninvasive ventilation added if they breached safety criteria after reaching the primary outcome. Eighteen patients initially allocated to home oxygen therapy alone had home noninvasive ventilation added to their management strategy.…”

Comparison of Noninvasive Mechanical Ventilation Volume Assured Pressure Support Mode With Manual Pressure Support in Acute Respiratory Failure of Chronic Obstructive Pulmonary Disease

“…26,27 Hasta uyanıkken ayarlanan tolere edebileceği basınç desteği, hasta uyurken noktürnal hipoventilasyonu kontrol etmeyebilir. 32 Ayrıca yüksek basınçlar bazı hastalar tarafından tolere edilemeyebilir. Fazla ve gereksiz basınç desteği hasta toleransını ve rahatını bozan majör nedendir.…”

Supplemental Oxygen Needs During Sleep. Who Benefits?

“…132 The largest and most recent trial, by McEvoy and colleagues, used NIV in patients with stable hypercapnic COPD already on long-term oxygen therapy, and showed a significant improvement in adjusted mortality. 133 However, the improvement in mortality with NIV was associated with a worse quality of life in the NIV treat group. Windisch and colleagues use what they call "highintensity NIV," with very high driving pressures (average inspiratory pressure 28 cm H 2 O, average expiratory pressure 5 cm H 2 O) and a high breathing frequency of about 21 breaths/min in those with severe COPD.…”