Management of Breathlessness With High-flow Nasal Therapy or a Fan
Primary Purpose
Breathlessness, Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
High-flow nasal therapy
Airflow directed to face by a fan
Sponsored by
About this trial
This is an interventional treatment trial for Breathlessness
Eligibility Criteria
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
Sites / Locations
- Pirkanmaa HospiceRecruiting
- Tampere University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fan first
High-flow nasal therapy first
Arm Description
Patients use the fan first and high-flow nasal therapy thereafter
Patients use high-flow nasal therapy first and the fan thereafter
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
Change in respiratory frequency with the treatments
Change in respiratory frequency measured by calculating breaths per minute.
Change in heart rate with the treatments
Change in heart rate measured by calculating heart beats per minute.
Change in oxygen saturation with the treatments
Change in peripheral oxygen saturation (%) measured with pulse oximeter.
Proportion of patients reporting to have overall benefit of the treatments
Proportion of patients reporting to have overall benefit of the treatments
Proportion of patients who report side-effects of the treatments
Proportion of patients who report side-effects of the treatments
Full Information
NCT ID
NCT05257850
First Posted
January 16, 2022
Last Updated
April 26, 2022
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05257850
Brief Title
Management of Breathlessness With High-flow Nasal Therapy or a Fan
Official Title
Management of Breathlessness With High-flow Nasal Therapy or a Fan
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathlessness, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fan first
Arm Type
Active Comparator
Arm Description
Patients use the fan first and high-flow nasal therapy thereafter
Arm Title
High-flow nasal therapy first
Arm Type
Active Comparator
Arm Description
Patients use high-flow nasal therapy first and the fan thereafter
Intervention Type
Device
Intervention Name(s)
High-flow nasal therapy
Intervention Description
A high-flow nasal therapy for 30 minutes.
Intervention Type
Device
Intervention Name(s)
Airflow directed to face by a fan
Intervention Description
A fan directed to the face for 30 minutes
Primary Outcome Measure Information:
Title
Breathlessness after the study treatments (difference between the High-Flow Nasal Therapy and a fan)
Description
The breathlessness after the study treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Secondary Outcome Measure Information:
Title
Change in breathlessness before and after the treatments
Description
Change in breathlessness before and after the treatments measured by numeric rating scale (NRS) from 0 (no breathlessness) to 10 (the worst possible breathlessness).
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Change in mouth dryness before and after the treatments
Description
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).
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Change in anxiety before and after the treatments
Description
Change in anxiety before and after the treatments measured by numeric rating scale (NRS) from 0 (no anxiety) to 10 (the worst possible anxiety).
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Change in pain before and after the treatments
Description
Change in pain before and after the treatments measured by numeric rating scale (NRS) from 0 (no pain) to 10 (the worst possible pain).
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Change in respiratory frequency with the treatments
Description
Change in respiratory frequency measured by calculating breaths per minute.
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Change in heart rate with the treatments
Description
Change in heart rate measured by calculating heart beats per minute.
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Change in oxygen saturation with the treatments
Description
Change in peripheral oxygen saturation (%) measured with pulse oximeter.
Time Frame
Measurements are made immediately before and immediately after the treatment period.
Title
Proportion of patients reporting to have overall benefit of the treatments
Description
Proportion of patients reporting to have overall benefit of the treatments
Time Frame
Opinion is asked immediately after the treatment
Title
Proportion of patients who report side-effects of the treatments
Description
Proportion of patients who report side-effects of the treatments
Time Frame
Experienced side-effects are asked immediately after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juho Lehto, Professor
Phone
+358504090974
Email
juho.lehto@tuni.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Reetta Piili, PhD
Phone
+358444729369
Email
reetta.piili@tuni.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juho Lehto, Professor
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pirkanmaa Hospice
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarja Korhonen, MD
Phone
+358331174204
Email
tarja.korhonen@pirkanmaanhoitokoti.fi
First Name & Middle Initial & Last Name & Degree
Juho Lehto, Professor
Phone
+358504090974
Email
juho.lehto@tuni.fi
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juho Lehto, Professor
Phone
+358504090974
Email
juho.lehto@tuni.fi
First Name & Middle Initial & Last Name & Degree
Reetta Piili, PhD
Phone
+358444729369
Email
reetta.piili@tuni.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Management of Breathlessness With High-flow Nasal Therapy or a Fan
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