Management of Breathlessness With High-flow Nasal Therapy or a Fan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Management of Breathlessness With High-flow Nasal Therapy or a Fan

Conditions
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Breathlessness, Cancer

Intervention / Treatment
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* Device: High-flow nasal therapy
* Device: Airflow directed to face by a fan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fan first<br>Patients use the fan first and high-flow nasal therapy thereafter | Device: High-flow nasal therapy<br>* A high-flow nasal therapy for 30 minutes.<br>Device: Airflow directed to face by a fan<br>* A fan directed to the face for 30 minutes<br>|
| Active Comparator: High-flow nasal therapy first<br>Patients use high-flow nasal therapy first and the fan thereafter | Device: High-flow nasal therapy<br>* A high-flow nasal therapy for 30 minutes.<br>Device: Airflow directed to face by a fan<br>* A fan directed to the face for 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan) | The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness). | Measurements are made immediately before and immediately after the treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breathlessness before and after the treatments | Change in breathlessness before and after the treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness). | Measurements are made immediately before and immediately after the treatment period. | 
| Change in mouth dryness before and after the treatments | Change in mouth dryness before and after the treatments measured by numeric rating scale (NRS) from 0 (no mouth dryness) to 10 (the worst possible mouth dryness). | Measurements are made immediately before and immediately after the treatment period. | 
| Change in anxiety before and after the treatments | Change in anxiety before and after the treatments measured by numeric rating scale (NRS) from 0 (no anxiety) to 10 (the worst possible anxiety). | Measurements are made immediately before and immediately after the treatment period. | 
| Change in pain before and after the treatments | Change in pain before and after the treatments measured by numeric rating scale (NRS) from 0 (no pain) to 10 (the worst possible pain). | Measurements are made immediately before and immediately after the treatment period. | 
| Change in respiratory frequency with the treatments | Change in respiratory frequency measured by calculating breaths per minute. | Measurements are made immediately before and immediately after the treatment period. | 
| Change in heart rate with the treatments | Change in heart rate measured by calculating heart beats per minute. | Measurements are made immediately before and immediately after the treatment period. | 
| Change in oxygen saturation with the treatments | Change in peripheral oxygen saturation (%) measured with pulse oximeter. | Measurements are made immediately before and immediately after the treatment period. | 
| Proportion of patients reporting to have overall benefit of the treatments | Proportion of patients reporting to have overall benefit of the treatments | Opinion is asked immediately after the treatment | 
| Proportion of patients who report side-effects of the treatments | Proportion of patients who report side-effects of the treatments | Experienced side-effects are asked immediately after the treatment |