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The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study

Primary Purpose

Dyspnea

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
handheld fan directed to cheeks
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring dyspnea, fan

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addenbrookes Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fan directed to cheeks

Arm Description

Blow draft of air generated by fan across cheeks

Outcomes

Primary Outcome Measures

Primary outcome measure is time in minutes for which breathlessness is improved after 5 minutes use of the fan directed at the face

Secondary Outcome Measures

Relief from breathlessness noted on relief score after using the handheld fan
Correlation between VAS and NRS scales

Full Information

First Posted
September 9, 2009
Last Updated
January 30, 2015
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
St Catherines Hospice, Scarborough acute hospitals Trust, University hospitals Morecambe Bay, St Johns Hospice
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1. Study Identification

Unique Protocol Identification Number
NCT00974558
Brief Title
The Use of a Handheld Fan to Manage Breathlessness - A Feasibility 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
St Catherines Hospice, Scarborough acute hospitals Trust, University hospitals Morecambe Bay, St Johns Hospice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
dyspnea, fan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fan directed to cheeks
Arm Type
Experimental
Arm Description
Blow draft of air generated by fan across cheeks
Intervention Type
Device
Intervention Name(s)
handheld fan directed to cheeks
Other Intervention Name(s)
handheld fan
Intervention Description
Handheld fan directed to cheeks for 5 minutes
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Relief from breathlessness noted on relief score after using the handheld fan
Time Frame
2 hours
Title
Correlation between VAS and NRS scales
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Galbraith, BM
Organizational Affiliation
Cambridge UNiversity Hospitals NHS Foundation Trust Addenbrookes Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Booth, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambs
ZIP/Postal Code
Cb2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

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The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study

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