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NCT Number: NCT05257850

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

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.

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Key information

Conditions

Breathlessness Cancer Dyspnea Neoplasms Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pirkanmaa Hospice, Tampere, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-flow nasal therapy

Device

A high-flow nasal therapy for 30 minutes.

Airflow directed to face by a fan

Device

A fan directed to the face for 30 minutes

Primary outcomes

  1. Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)

    Time frame: 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).

Secondary outcomes

  1. Change in breathlessness before and after the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    Change in breathlessness before and after the treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).

  2. Change in mouth dryness before and after the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    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).

  3. Change in anxiety before and after the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    Change in anxiety before and after the treatments measured by numeric rating scale (NRS) from 0 (no anxiety) to 10 (the worst possible anxiety).

  4. Change in pain before and after the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    Change in pain before and after the treatments measured by numeric rating scale (NRS) from 0 (no pain) to 10 (the worst possible pain).

  5. Change in respiratory frequency with the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    Change in respiratory frequency measured by calculating breaths per minute.

  6. Change in heart rate with the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    Change in heart rate measured by calculating heart beats per minute.

  7. Change in oxygen saturation with the treatments

    Time frame: Measurements are made immediately before and immediately after the treatment period.

    Change in peripheral oxygen saturation (%) measured with pulse oximeter.

  8. Proportion of patients reporting to have overall benefit of the treatments

    Time frame: Opinion is asked immediately after the treatment

    Proportion of patients reporting to have overall benefit of the treatments

  9. Proportion of patients who report side-effects of the treatments

    Time frame: Experienced side-effects are asked immediately after the treatment

    Proportion of patients who report side-effects of the treatments

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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