ArticlesPalliative use of non-invasive ventilation in end-of-life patients with solid tumours: a randomised feasibility trial
Introduction
Respiratory symptoms and dyspnoea are commonly reported in patients with solid tumours, with a prevalence ranging from 20% to 80%.1 Despite best-possible medical management, many patients are often breathless, especially in the latter stages of their life.2 Opioids provide symptomatic improvement in patients with less advanced disease—when acute respiratory distress is not yet present3—but little research has been done into the effect of oxygen in patients with cancer with refractory dyspnoea.4 There are some suggestions, however, that non-invasive ventilation (NIV) might be an alternative option to relieve dyspnoea in patients with end-stage cancer, including those with solid tumours.5 For this reason, the Society of Critical Care Medicine set up a task force to examine and potentially justify the use of NIV for patients in the palliative care setting.6 The members of the task force stated that most patients and their relatives are interested in ensuring comfort in the later stages of their disease, but some might also want to maintain cognition and the ability to communicate.6 In this context, NIV would be effective if it improves breathlessness and respiratory distress without having other negative consequences, such as discomfort from a tight-fitting face mask or an undue delay in the time of death. Studies on the effect of pharmacological treatments such as oxygen4 and morphine3 to relieve the burden of refractory dyspnoea in patients with end-stage cancer have not included people with severe respiratory distress—those who are most burdened by the symptom. Similarly, non-pharmacological treatments, such as NIV, have not been systematically studied.
The main objectives of this study were to assess the acceptability of NIV (used solely as a palliative measure) versus oxygen therapy and its effectiveness in reducing dyspnoea, the amount of opiates needed during NIV treatment, the recruitment and consent rate in a trial of NIV, and the variability of dyspnoea and morphine use to calculate sample sizes for future definitive studies.
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Patients
In this multicentre, stratified, randomised feasibility study, designed according to the recommendations for good practice,7 done in five respiratory intensive care units and two critical care units of emergency departments (in Italy, Spain, and Taiwan), we enrolled consecutive patients who had end-stage cancer and solid tumours admitted to hospital because of acute respiratory failure and distress, and who had chosen to forego all life support and receiving only palliative care. The definition
Results
Between Jan 15, 2008, and March 9, 2011, 441 consecutive patients with cancer and acute respiratory failure were screened for eligibility for the trial. 234 patients were eligible for recruitment, of whom 200 (85%) were randomly allocated to treatment (all 234 eligible patients underwent the NIV run-in demonstration; figure 1). Baseline characteristics were much the same between individuals who received NIV and those who received oxygen (table 1; see appendix for baseline characteristics by PaCO
Discussion
Our findings suggest that NIV is well accepted by patients, is more effective in reducing dyspnoea compared with oxygen therapy, and requires less morphine than does oxygen therapy. We know of no other randomised trial assessing the feasibility of NIV as a palliative measure in comparison with oxygen in terminally ill patients with solid tumours and acute respiratory failure and distress. Our recruitment and consent rate was good, with 85% of eligible patients participating in the trial
References (37)
- et al.
Clinical management of dyspnoea
Lancet Oncol
(2002) - et al.
Effect of palliative oxygen versus room air in relief of breathessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial
Lancet
(2010) - et al.
Non-invasive ventilation in acute respiratory failure
Lancet
(2009) - et al.
Prevalence and severity of neurologic dysfunction in critically ill patients
Chest
(1993) - et al.
The course of symptom frequency and intensity in advanced cancer patients followed at home
J Pain Symptom Manage
(2000) - et al.
Symptomatic benefit of supplemental oxygen in hypoxemic patients with terminal cancer: the use of the N of 1 randomized controlled trial
J Pain Symptom Manage
(1992) - et al.
Effects of oxygen on dyspnoea in hypoxaemic terminal-cancer patients
Lancet
(1993) - et al.
Nocturnal noninvasive ventilation
Chest
(2008) - et al.
The frequency and timing of respiratory depression in 1524 postoperative patients treated with systemic or neuraxial morphine
J Clin Anesth
(2005) - et al.
Allocation concealment in randomized trials: defending against deciphering
Lancet
(2002)