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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
St Catherines Hospice
Scarborough acute hospitals Trust
University hospitals Morecambe Bay
St Johns Hospice
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00974558
First received: September 9, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Dyspnea
Device: handheld fan directed to cheeks

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relief from breathlessness noted on relief score after using the handheld fan [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Correlation between VAS and NRS scales [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: January 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fan directed to cheeks Device: handheld fan directed to cheeks
Handheld fan directed to cheeks for 5 minutes
Other Name: handheld fan

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974558

Contacts
Contact: Sarah Galbraith, BM +44 1223 274404 sarah.galbraith@addenbrookes.nhs.uk
Contact: Sara Booth, MD +44 1223 586703 sara.booth@addenbrookes.nhs.uk

Locations
United Kingdom
Addenbrookes Hospital Recruiting
Cambridge, Cambs, United Kingdom, Cb2 0QQ
Contact: Sarah Galbraith, BM       sarah.galbraith@addenbrooeks.nhs.uk   
Principal Investigator: Sarah Galbraith, BM         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
St Catherines Hospice
Scarborough acute hospitals Trust
University hospitals Morecambe Bay
St Johns Hospice
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
  More Information

No publications provided

Responsible Party: Dr Sarah Galbraith, Addenbrookes Hospital
ClinicalTrials.gov Identifier: NCT00974558     History of Changes
Other Study ID Numbers: A091619
Study First Received: September 9, 2009
Last Updated: June 22, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
dyspnea
fan

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 25, 2014