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

NCT ID: NCT05257850

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-26

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breathlessness Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fan first

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

Group Type ACTIVE_COMPARATOR

High-flow nasal therapy

Intervention Type DEVICE

A high-flow nasal therapy for 30 minutes.

Airflow directed to face by a fan

Intervention Type DEVICE

A fan directed to the face for 30 minutes

High-flow nasal therapy first

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

Group Type ACTIVE_COMPARATOR

High-flow nasal therapy

Intervention Type DEVICE

A high-flow nasal therapy for 30 minutes.

Airflow directed to face by a fan

Intervention Type DEVICE

A fan directed to the face for 30 minutes

Interventions

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High-flow nasal therapy

A high-flow nasal therapy for 30 minutes.

Intervention Type DEVICE

Airflow directed to face by a fan

A fan directed to the face for 30 minutes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Juho Lehto

MD,PhD,Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juho Lehto, Professor

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Pirkanmaa Hospice

Tampere, , Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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Leivo-Korpela S, Rantala HA, Lehtimaki L, Piili RP, Hasala H, Korhonen T, Lehto JT. Management of dyspnea with high-flow nasal air or fan - a randomized controlled crossover trial. J Pain Symptom Manage. 2025 Sep 4:S0885-3924(25)00813-9. doi: 10.1016/j.jpainsymman.2025.08.033. Online ahead of print.

Reference Type DERIVED
PMID: 40914402 (View on PubMed)

Other Identifiers

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R20049

Identifier Type: -

Identifier Source: org_study_id

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