Multicenter, Randomised Study of the Use of Non-Invasive Ventilation (NIV) Versus Oxygen Therapy (O2) in Reducing Dyspnea in End-stage Solid Cancer Patients With Respiratory Failure and Distress
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- dyspnea
研究概览
简要总结
The occurrence of acute respiratory failure (ARF) is often seen by oncologists as a terminal phase of the disease, this view being based on studies reporting limited survival at considerable costs in such patients. A large proportion of cancer patients with severe respiratory failure are denied admission to an ICU because intensive care specialists are aware that intubation and mechanical ventilation are both strong predictors of mortality in critically ill cancer patients. This holds particularly true in the subset of patients who are not receiving chemotherapy or radiotherapy because of the advanced stage of their disease, and who are also not affected by an episode of ARF, related to a reversible cause.
These patients often receive oxygen therapy and morphine in an attempt to improve oxygenation and/or relieve the ensuing dyspnea.
Non-invasive mechanical ventilation (NIV) is now the first line treatment of ARF in selected populations (e.g., those with COPD) and has been used sporadically as a potential treatment of acute respiratory failure in patients with a "do-not-intubate" order. The International Consensus Conference on Intensive Care Medicine stated that "the use of NIV may be justified in selected patients who are "not to be intubated" and may provide patient comfort and facilitate physician-patient interaction." "Early" NIV has been successfully used so far in cancer patients only to prevent intubation among those with hematologic malignancies, while a pilot study has assessed the feasibility of NIV also as a "palliative" treatment of end-stage solid cancer patients. So far we are lacking data about the "pure palliative" effects of NIV,in patients with end-stage solid cancer.
The aim of this multicenter randomised study will be to evaluate on a large scale the feasibility, clinical efficacy and impact on quality of life and dyspnea of NIV versus standard medical in patients with respiratory failure, not related to a reversible cause, and solid cancer needing palliative care treatment.
详细描述
Rationale:
The occurrence of ARF is often seen by oncologists as a terminal phase of the disease, this view being based on studies reporting limited survival at considerable costs in such patients (1, 2, 3, 4, 5, 6). A large proportion of cancer patients with severe respiratory failure are denied admission to an ICU because intensive care specialists are aware that intubation and mechanical ventilation are both strong predictors of mortality in critically ill cancer patients (1, 3, 5, 7). This holds particularly true in the subset of patients who are not receiving chemotherapy or radiotherapy because of the advanced stage of their disease, and who are also not affected by an episode of ARF, related to a reversible cause.
These patients often receive oxygen therapy and morphine in an attempt to improve oxygenation and/or relief the ensuing dyspnea.
Non-invasive mechanical ventilation (NIV) is now the first line treatment of ARF in selected populations (e.g. those with COPD) (8) and has been used sporadically as a potential treatment of acute respiratory failure in patients with a "do-not-intubate" order (9). The International Consensus Conference on Intensive Care Medicine stated that "the use of NIV may be justified in selected patients who are "not to be intubated" and may provide patient comfort and facilitate physician-patient interaction" (8). "Early" NIV has been successfully used so far in cancer patients only to prevent intubation among those with hematologic malignancies (10), while a pilot study has assessed the feasibility of NIV also as a "palliative" treatment of end-stage solid cancer patients (11). So far we are lacking data about the "pure palliative" effects of NIV,in patients with end-stage solid cancer.
Aim. The aim of this multicenter randomised study will be to evaluate on a large scale the feasibility, clinical efficacy and impact on quality of life and dyspnea of NIV vs standard medical in patients with respiratory failure, not related to a reversible cause, and solid cancer needing palliative care treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major criteria for enrollment into the study were one of the following:
- •PaO2/FiO2 ratio < 250 + one of the two following:
- •dyspnea with recruitment of the accessory muscles and/or abdominal muscles recruitment; and
- •respiratory rate > 30 b/ min. Hypercapnia per se is not a criteria of inclusion, but it is not an exclusion criteria if chronic.
排除标准
- •Potentially reversible causes of exacerbation such as (CPE, pneumonia or exacerbation of chronic pulmonary disorders) coma
- •Refusal of treatment
- •Inability to protect the airways
- •An agitated or uncooperative patient
- •Anatomical abnormalities interfering with mask fit
- •Uncontrolled cardiac ischemia or arrhythmias
- •Failure of more than two organs
结局指标
主要结局
dyspnea
时间窗: 48 hours
morphine dosage
时间窗: 48 hours
Quality of Life
时间窗: 48 hours
次要结局
- Arterial Blood Gases(48 hours)
- Survival(48 hours)
研究者
dr. Stefano Nava
Chief ICU
IRCCS Azienda Ospedaliero-Universitaria di Bologna