Management of Dyspnea With High- Flow Nasal Therapy

NCT07552935 | Not Yet Recruiting

• 1 other identifier: R26040
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Palliative Care; Breathlessness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in breathlessness before and after treatments

  Measurements are made immediately before and immediately after the treatment period.

• 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

  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

  Measurements are made immediately before and immediately after the treatment period.

• Change in respiratory frequency with the treatments

  Measurements are made immediately before and immediately after the treatment period.

Study Arms (2)

Group A, HFNT first

ACTIVE COMPARATOR

Patients use high-flow nasal therapy first and the fan thereafter

Device: High-flow nasal therapy; Device: Airflow directed to face by a fan

Group B, Fan first

ACTIVE COMPARATOR

Patients use the fan first and high-flow nasal therapy thereafter

Device: High-flow nasal therapy; Device: Airflow directed to face by a fan

Interventions

High-flow nasal therapy DEVICE

A high-flow nasal therapy for 30 minutes.

Group A, HFNT first; Group B, Fan first

Airflow directed to face by a fan DEVICE

Airflow directed to face by a fan for 30 minutes

Group A, HFNT first; Group B, Fan first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juho Lehto, Professor

  Tampere University Hospital and Tampere University, Tampere, Finland.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juho Lehto, Professor

CONTACT

+358 50 4090974; juho.lehto@tuni.fi

Sirpa Leivo-Korpela, MD, PhD

CONTACT

+ 358 44 485 8055; sirpa.leivo-korpela@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Anonymous data will be available from the Central Contact Person upon a reasonable request after the study have been completed.