Management of Dyspnea With High- Flow Nasal Therapy (HFNTpal)

Dyspnea in patients with incurable illness is a difficult symptom. Therefore, there is 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, 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.

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.

Each patient receives HFNT and fan therapy in which airflow will be directed toward the patient's face. Both treatments will last 30 minutes. Patient symptoms will be asked after the treatments. 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 relief of dyspnea with HFNT compared with fan therapy.

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. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow patients to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study.

If successful, the study will significantly improve the care of the patients in palliative care.

Study Overview

• Status: Not yet recruiting
• Conditions: Palliative Care; Breathlessness
• Intervention / Treatment: Device: High-flow nasal therapy; Device: Airflow directed to face by a fan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juho Lehto, Professor; Phone Number: +358 50 4090974; Email: juho.lehto@tuni.fi
• Study Contact Backup: Name: Sirpa Leivo-Korpela, MD, PhD; Phone Number: + 358 44 485 8055; Email: sirpa.leivo-korpela@pirha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient is in palliative care (ICD-10 diagnostic code Z51.5 palliative care)
• Age ≥ 18 years
• Ability to understand the study and provide informed consent to participate
• Significant breathlessness (NRS = Numeric Rating Scale ≥ 4).
• The treating physician has assessed that the patient would not benefit from treatment in intensive care unit or monitor unit.
• The treating physician has assessed that the patient would not benefit from invasive mechanical ventilation (intubation) or cardiopulmonary resuscitation.

Exclusion Criteria:

• Decreased level of consciousness, delirium, or other lack of cooperation that prevents participation.
• Respiratory support other than HFNT is required.
• The patient has received HFNT during the same admission to palliative care ward or hospice.
• The cause of dyspnea can be treated immediately.
• Inability to provide informed consent to participate.

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: Group A, HFNT 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; Airflow directed to face by a fan for 30 minutes
Active Comparator: Group B, 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; Airflow directed to face by a fan for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in breathlessness with HFNT compared with fan therapy	Change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by the HFNT compared to the change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by fan therapy.	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 treatments	Change in the breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) by HFNT and fan therapy	Measurements are made immediately before and immediately after the treatment period.
Breathlessness after the HFNT compared to fan therapy	Breathlessness measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness) after the HFNT compared to fan therapy.	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	Proportion of patients reporting 1 or more points decrease in numeric rating scale (NRS) for breathlessness from 0 (no breathlessness) to 10 (the worst possible breathlessness) by the HFNT and fan therapy.	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	Change in cough, respiratory secretions, mouth dryness, pain and anxiety measured by numeric rating scale (NRS) from 0 (no symptom) to 10 (the worst possible symptom) by HFNT and fan therapy.	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 before and after HFNT and fan therapy.	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 before and after the HFNT and fan therapy.	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 before and after the HFNT and fan therapy.	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 HFNT and fan therapy	Opinion is asked immediately after the treatments
Proportion of patients who report side-effects of the treatments	Proportion of patients who report side-effects of the HFNT and fan therapy	Experienced side-effects are asked immediately after the treatments
Proportion of patients not complying with the treatments	Proportion of patients not complying with the HFNT and fan therapy	Compliance is measured immediately after the treatment periods
Proportion of patients preferring HFNT over fan therapy	Proportion of patients preferring HFNT over fan therapy	Preference is asked immediately after both interventions have been performed
Proportion of patients preferring HFNT over conventional oxygen therapy	In patients, who have used conventional oxygen therapy, the proportion of patients preferring HFNT over conventional oxygen therapy is measured.	Preference is asked immediately after the HFNT intervention, if the patient have used conventional oxygen therapy before the intervention.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspnea
• Other Study ID Numbers: R26040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous data will be available from the Central Contact Person upon a reasonable request after the study have been completed.
• IPD Sharing Time Frame: Anonymous data will be available from the Central Contact Person upon a reasonable request after the study have been completed. The study recruitment is estimated to end by the end of 2029.
• IPD Sharing Access Criteria: Anonymous data will be available from the Central Contact Person upon a reasonable request after the study have been completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No