Management of Breathlessness with High-flow Nasal Therapy or a Fan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)
研究概览
简要总结
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared.
40 patients with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan. Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.
详细描述
Airflow directed to the face by a fan is shown to relief breathlessness in palliative care and some studies have suggested High-Flow nasal airflow therapy beneficial as well. However, these two treatments have not been compared and High-Flow nasal airflow therapy has not been tested in the context of hospice.
40 patients over 18 years with advanced cancer and breathlessness are recruited from Tampere University Hospital or Pirkanmaa Hospice. All patients are treated with two therapies: 1. High-Flow nasal airflow therapy with a nasal cannula and 2. airflow directed to the face by a fan (crossover trial). Both treatment periods last 30 minutes or as long as the patient wish to use the therapy. The effects of the therapies on breathlessness are compared by asking the subjective relief of breathlessness after each therapies with numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness). Influence of the treatments on anxiety, pain and mouth dryness are measured as well with numeric rating scale (NRS) from 0 to 10. The study do not limit any other therapies used in the normal clinical care for the patients. Thus, all the other therapies the physicians taking care of the patient orders are permitted. Hopefully, the patients achieve relief for their breathlessness through the study treatments given in addition to their normal treatment. There are no significant risks related to the therapies, but they may cause some inconveniences such as mouth dryness. These possible side-effects of the therapies are asked as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced cancer
- •At least 18 years of age
- •Breathlessness (At least 3 on a NRS-scale from 0 to 10)
- •Capable to understand the study and to give informed consent
- •Do not benefit from ICU treatment or resuscitation defined by the physician taking care of the patient
排除标准
- •Insufficient co-operation for the study treatment or to give informed consent
- •Oxygen saturation under 88 % on room air
- •Need for other device to treat the breathlessness
- •The reason of breathlessness can be immediately treated
结局指标
主要结局
Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)
时间窗: Measurements are made immediately before and immediately after the treatment period.
The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).
次要结局
- Change in anxiety before and after the treatments(Measurements are made immediately before and immediately after the treatment period.)
- Change in pain before and after the treatments(Measurements are made immediately before and immediately after the treatment period.)
- Change in heart rate with the treatments(Measurements are made immediately before and immediately after the treatment period.)
- Proportion of patients reporting to have overall benefit of the treatments(Opinion is asked immediately after the treatment)
- Change in breathlessness before and after the treatments(Measurements are made immediately before and immediately after the treatment period.)
- Proportion of patients who report side-effects of the treatments(Experienced side-effects are asked immediately after the treatment)
- Change in respiratory frequency with the treatments(Measurements are made immediately before and immediately after the treatment period.)
- Change in mouth dryness before and after the treatments(Measurements are made immediately before and immediately after the treatment period.)
- Change in oxygen saturation with the treatments(Measurements are made immediately before and immediately after the treatment period.)
研究者
Juho Lehto
MD,PhD,Professor
Tampere University Hospital