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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05257850
Other study ID # R20049
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Tampere University Hospital
Contact Juho Lehto, Professor
Phone +358504090974
Email juho.lehto@tuni.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
High-flow nasal therapy
A high-flow nasal therapy for 30 minutes.
Airflow directed to face by a fan
A fan directed to the face for 30 minutes

Locations

Country Name City State
Finland Pirkanmaa Hospice Tampere
Finland Tampere University Hospital Tampere

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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
Secondary 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
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