Management of Dyspnea With High- Flow Nasal Therapy

Management of Dyspnea with High-Flow Nasal Therapy

Dyspnea in patients with incurable illness is a difficult-to-manage symptom that markedly impairs quality of life. Especially toward the end of life, the severity of dyspnea increases and the response to treatments decreases. Frail patients often tolerate mask-based therapies poorly. Therefore, there remains a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea in cancer patients, and similarly that directing airflow toward the face can provide relief. HFNT has been studied very little in hospice settings and on palliative care wards. The aim of this study is to determine whether HFNT is a feasible and effective treatment for relieving dyspnea in patients receiving palliative care in the care settings where these patients are usually treated.

Patients will be recruited from the Hatanpää Palliative Care Ward and the Pirkanmaa Hospice, Tampere, Finland. The target is to recruit approximately 30-40 patients. The inclusion criteria are: age ≥18 years, ability to understand the study and provide informed consent to participate, a palliative treatment approach, and significant dyspnea defined as ≥4 on the NRS (Numerical Rating Scale). Patients will be offered the opportunity to participate in the study and will be provided with written materials, including the study information sheet and consent form, for review. Patients will be given sufficient time to consider participation. Those who choose to participate will provide written informed consent.

The study will be conducted using a crossover design in which each patient receives two treatment interventions. In one intervention, the patient will receive HFNT, and in the other, airflow will be directed toward the patient's face using a fan. Supplemental oxygen will be used if the patient requires it. Each intervention will last 30 minutes. Patient symptoms will be asked using the NRS scale before and after the interventions. In addition, patients will be asked to rate the overall benefit they experienced from the intervention and any side effects. The primary endpoint is the change in dyspnea on the NRS scale with HFNT compared with fan therapy. Based on the sample size calculation, the total number of patients required is approximately 30-40.

The study will be conducted in accordance with laws, regulations, and guidelines governing medical research, as well as good scientific practice and research ethics. The study does not involve significant risks or measurements or sampling procedures that would cause additional discomfort. All other care for the patient will be provided according to the standard practices of the treating unit, and participation in the study will not limit any necessary treatments. Study data will be stored confidentially in accordance with the data protection statement. Data containing direct or indirect identifiers and code keys will be destroyed after completion of the study. Fully anonymized data will be archived securely, as it may be needed for meta-analyses of similar studies. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow individual patients or their relatives to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study (R26040).

If successful, the study will significantly improve the care of the patients in palliative care and help to alleviate their suffering.

• Change in breathlessness before and after treatments [Срок оценки: Measurements are made immediately before and immediately after the treatment period.]
• Breathlessness after the HFNT compared to fan therapy [Срок оценки: Measurements are made immediately after the treatment periods.]
• Proportion of patients reporting 1 or more points decrease in NRS scale for breathlessness by the treatments [Срок оценки: Measurements are made immediately before and immediately after the treatment period.]
• Change in cough, respiratory secretions, mouth dryness, pain and anxiety before and after the treatments [Срок оценки: Measurements are made immediately before and immediately after the treatment period.]
• Change in respiratory frequency with the treatments [Срок оценки: Measurements are made immediately before and immediately after the treatment period.]
• Change in oxygen saturation with the treatments [Срок оценки: Measurements are made immediately before and immediately after the treatment period.]
• Change in heart rate with the treatments [Срок оценки: Measurements are made immediately before and immediately after the treatment period]
• Proportion of patients reporting to have overall benefit of the treatments [Срок оценки: Opinion is asked immediately after the treatments]
• Proportion of patients who report side-effects of the treatments [Срок оценки: Experienced side-effects are asked immediately after the treatments]
• Proportion of patients not complying with the treatments [Срок оценки: Compliance is measured immediately after the treatment periods]
• Proportion of patients preferring HFNT over fan therapy [Срок оценки: Preference is asked immediately after both interventions have been performed]
• Proportion of patients preferring HFNT over conventional oxygen therapy [Срок оценки: Preference is asked immediately after the HFNT intervention, if the patient have used conventional oxygen therapy before the intervention.]