Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00974558
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2009-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: