- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00974558
The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cambs
-
Cambridge, Cambs, United Kingdom, Cb2 0QQ
- Addenbrookes Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fan directed to cheeks
Blow draft of air generated by fan across cheeks
|
Handheld fan directed to cheeks for 5 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relief from breathlessness noted on relief score after using the handheld fan
Time Frame: 2 hours
|
2 hours
|
|
Correlation between VAS and NRS scales
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarah Galbraith, BM, Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital
- Study Director: Sara Booth, MD, Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A091619
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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