NCT00974558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

September 9, 2009

Last Update Submit

January 30, 2015

Conditions

Keywords

dyspneafan

Outcome Measures

Primary Outcomes (1)

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

    2 hours

Secondary Outcomes (2)

  • Relief from breathlessness noted on relief score after using the handheld fan

    2 hours

  • Correlation between VAS and NRS scales

    2 hours

Study Arms (1)

fan directed to cheeks

EXPERIMENTAL

Blow draft of air generated by fan across cheeks

Device: handheld fan directed to cheeks

Interventions

Handheld fan directed to cheeks for 5 minutes

Also known as: handheld fan
fan directed to cheeks

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cambs, Cb2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Galbraith, BM

    Cambridge UNiversity Hospitals NHS Foundation Trust Addenbrookes Hospital

    PRINCIPAL INVESTIGATOR
  • Sara Booth, MD

    Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in palliative medicine

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations