DyspneaNCT00974558
The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study
A study testing handheld fan directed to cheeks in people with Dyspnea, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of the study is to investigate if the use of a handheld fan directed to the cheeks alongside conventional medical treatment partially or totally relieves breathlessness and if this effect lasts for at least 30 minutes in patients irrespective of the underlying disease process. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- handheld fan directed to cheeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient able and willing to cooperate with the study and who defines themselves as breathless at rest by answering 'yes' to the question, 'Do you currently feel short of breath?'
- Any diagnosis causing breathlessness
- Age >3 0years
Who cannot join
- Patients who have previously used a handheld fan to manage their breathlessness
- Patients with fever >38 0C in last 24 hours
- Patients on continuous oxygen
- Patients requiring short burst oxygen therapy whilst completing the study
- Patients with diseases or treatment affecting the trigeminal nerve supply.
- Patients with other diseases which, in the opinion of the researcher or investigator, may affect the mechanism of action of the fan
- Patients unable to understand or cooperate with study
- Patients who do not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of a Handheld Fan to Improve Breathlessness - a Feasibility Study to Assess Relief From Breathlessness After Five Minutes Use of a Handheld Fan Directed at the Cheeks
The aim of the study is to investigate if the use of a handheld fan directed to the cheeks alongside conventional medical treatment partially or totally relieves breathlessness and if this effect lasts for at least 30 minutes in patients irrespective of the underlying disease process.
Read the detailed description
A previous randomised controlled trial (Galbraith et al, accepted for publication) has shown a reduction in breathlessness after 5 minutes use of a fan directed to the cheeks. This study is a feasibility study to determine how long this beneficial effect lasts.
With the patient in a relaxed sitting position and ensuring there is no other fan or open window blowing air onto the subject, the following will be explained to the patient and then measured and recorded
- Numerical Rating Scale (NRS) for dyspnoea
- Visual analogue scale (VAS) for breathlessness with end anchors
- O2 saturation using pulse oximeter
- Pulse rate using pulse oximeter
- Room temperature and humidity recorded
The patients will be asked to avoid talking or significantly change position throughout the study.
Fan to cheeks The investigator will demonstrate to the patient how to use the handheld fan directed to the cheeks. The appropriate area on the face, which corresponds to the area innervated by 2nd and 3rd trigeminal nerve branches, will be demonstrated by the researcher. The patient will then use the fan as demonstrated and this will be timed for 5 minutes with the patient in a relaxed sitting position.
Assessment following treatment with fan After 5 minutes use of the fan directed at cheeks, the following will be recorded immediately
- NRS and VAS for dyspnoea
- Relief score, a 5 point rating of how much relief from breathlessness the participant has obtained (0=nil, 1= a little relief , 2= moderate relief, 3=good relief, 4=no longer breathless/maximal relief)
- O2 saturation
- Pulse rate
Participants who have had no improvement in breathlessness as measured by VAS, NRS or gained no relief assessed by the relief score will end the study at this point.
Participants who have an improvement in breathlessness will continue the study and NRS and VAS will to be recorded every 10 minutes in alternating order until the NRS or/and VAS have returned to baseline values or reached a steady level.
- Conditions
- Dyspnea
- Being tested
- handheld fan directed to cheeks
- Keywords
- dyspnea, fan
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handheld fan directed to cheeksDevice
Also called handheld fan
Handheld fan directed to cheeks for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| fan directed to cheeks | Experimental | Blow draft of air generated by fan across cheeks Receives: Device: handheld fan directed to cheeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is time in minutes for which breathlessness is improved after 5 minutes use of the fan directed at the face
Measured: 2 hours
Secondary outcomes (2)
Relief from breathlessness noted on relief score after using the handheld fan
Measured: 2 hours
Correlation between VAS and NRS scales
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St Catherines Hospice, Scarborough acute hospitals Trust, University hospitals Morecambe Bay, St Johns Hospice
- Responsible party
- Principal investigator, Sarah Galbraith, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Sarah Galbraith, BM, Principal investigator, Cambridge UNiversity Hospitals NHS Foundation Trust Addenbrookes HospitalSara Booth, MD, Study director, Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974558
- Sponsor's protocol ID
- A091619
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2009
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Handheld Fan to Improve Breathlessness - a Feasibility Study to Assess Relief From Breathlessness After Five Minutes Use of a Handheld Fan Directed at the Cheeks
- ClinicalTrials.gov ID
- NCT00974558
- Acronym / sponsor ID
- A091619
- Conditions
- Dyspnea
- Keywords
- dyspnea, fan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- St Catherines Hospice, Scarborough acute hospitals Trust, University hospitals Morecambe Bay, St Johns Hospice
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate if the use of a handheld fan directed to the cheeks alongside conventional medical treatment partially or totally relieves breathlessness and if this effect lasts for at least 30 minutes in patients irrespective of the underlying disease process.
Detailed description
A previous randomised controlled trial (Galbraith et al, accepted for publication) has shown a reduction in breathlessness after 5 minutes use of a fan directed to the cheeks. This study is a feasibility study to determine how long this beneficial effect lasts.
With the patient in a relaxed sitting position and ensuring there is no other fan or open window blowing air onto the subject, the following will be explained to the patient and then measured and recorded
- Numerical Rating Scale (NRS) for dyspnoea
- Visual analogue scale (VAS) for breathlessness with end anchors
- O2 saturation using pulse oximeter
- Pulse rate using pulse oximeter
- Room temperature and humidity recorded
The patients will be asked to avoid talking or significantly change position throughout the study.
Fan to cheeks The investigator will demonstrate to the patient how to use the handheld fan directed to the cheeks. The appropriate area on the face, which corresponds to the area innervated by 2nd and 3rd trigeminal nerve branches, will be demonstrated by the researcher. The patient will then use the fan as demonstrated and this will be timed for 5 minutes with the patient in a relaxed sitting position.
Assessment following treatment with fan After 5 minutes use of the fan directed at cheeks, the following will be recorded immediately
- NRS and VAS for dyspnoea
- Relief score, a 5 point rating of how much relief from breathlessness the participant has obtained (0=nil, 1= a little relief , 2= moderate relief, 3=good relief, 4=no longer breathless/maximal relief)
- O2 saturation
- Pulse rate
Participants who have had no improvement in breathlessness as measured by VAS, NRS or gained no relief assessed by the relief score will end the study at this point.
Participants who have an improvement in breathlessness will continue the study and NRS and VAS will to be recorded every 10 minutes in alternating order until the NRS or/and VAS have returned to baseline values or reached a steady level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fan directed to cheeks | Experimental | Device: handheld fan directed to cheeksBlow draft of air generated by fan across cheeks |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient able and willing to cooperate with the study and who defines themselves as breathless at rest by answering 'yes' to the question, 'Do you currently feel short of breath?'
- Any diagnosis causing breathlessness
- Age >3 0years
Key exclusion criteria (8 listed)
- Patients who have previously used a handheld fan to manage their breathlessness
- Patients with fever >38 0C in last 24 hours
- Patients on continuous oxygen
- Patients requiring short burst oxygen therapy whilst completing the study
- Patients with diseases or treatment affecting the trigeminal nerve supply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handheld fan directed to cheeksAlso: handheld fanHandheld fan directed to cheeks for 5 minutes | Device | fan directed to cheeks |
Primary outcome
Primary outcome measure is time in minutes for which breathlessness is improved after 5 minutes use of the fan directed at the face
Time frame: 2 hours
2 secondary outcomes
Relief from breathlessness noted on relief score after using the handheld fan
Time frame: 2 hours
Correlation between VAS and NRS scales
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Galbraith, BM principal investigator
Cambridge UNiversity Hospitals NHS Foundation Trust Addenbrookes Hospital
Sara Booth, MD study director
Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handheld fan directed to cheeks in people with Dyspnea, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure is time in minutes for which breathlessness is improved after 5 minutes use of the fan directed at the face (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.