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.

Study Overview

• Status: Completed
• Conditions: Cancer; Breathlessness
• Intervention / Treatment: Device: High-flow nasal therapy; Device: Airflow directed to face by a fan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Tampere University Hospital
  • Tampere, Finland, 33520
    • Pirkanmaa Hospice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Juho Lehto, Professor, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: R20049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No