Management of Dyspnea With High- Flow Nasal Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTampere University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
High-flow nasal therapy
DeviceA high-flow nasal therapy for 30 minutes.
Airflow directed to face by a fan
DeviceAirflow directed to face by a fan for 30 minutes
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group A, HFNT firstActive comparator 2 interventions
Group B: Group B, Fan firstActive comparator 2 interventions
Trial outcomes
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.
Time frame
Measurements are made immediately before and immediately after the treatment period.Secondary outcomes
1
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
Time frame
Measurements are made immediately before and immediately after the treatment period.2
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.
Time frame
Measurements are made immediately after the treatment periods.3
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.
Time frame
Measurements are made immediately before and immediately after the treatment period.4
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.
Time frame
Measurements are made immediately before and immediately after the treatment period.Sponsors and contacts
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Source ClinicalTrials.gov