The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
1 other identifier
interventional
14
1 country
1
Brief Summary
The Investigators aimed to assess primarily whether or not Hilotherapy masks are a tolerable treatment for the conservative management of epistaxis and nasal fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedFebruary 21, 2020
February 1, 2020
1.3 years
February 11, 2020
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Outcome 1 was to assess the feasibility of using the Hilotherm mask in the first line management of epistaxis in the Accident and Emergency setting.
The measurement tool used to assess feasibility was a non-validated patient questionnaire. The questionnaire was provided to participants after they had worn the mask. The questionnaire was named "patient questionnaire". The questions on the questionnaire were answered by ranking choices 1 to 5. 1= strongly agree, 2= agree, 3= neither agree or disagree, 4= disagree, 5= strongly agree. The questions were as follows; The Hilotherm mask was easy to fit, The Hilotherm mask felt secure and in place, The Hilotherm mask felt comfortable to wear, the Hilotherm mask caused me discomfort/felt uncomforatble to wear, I felt the Hilotherm mask reduced the amount my nose was bleeding, I felt the Hilotherm mask was kept on for too long, if I had a nose bleed I would wear the Hilotherm mask again to reduce the bleeding.
The outcome was measured using the patient questionnaire after the mask had been applied for 20 minutes, or in cases where epistaxis had been reduced by the mask, after 40 minutes.
Secondary Outcomes (1)
To assess the reduction in rate and severity of epistaxis when the Hilotherm mask was applied in conjunction with standard conservative measures to reduce epistaxis.
within 20 minutes of mask application
Study Arms (1)
participants enrolled with epistaxis and/or nasal fractures
EXPERIMENTALInterventions
a cooling mask used to treat localized swelling and bleeding
Eligibility Criteria
You may qualify if:
- presenting to ED with epistaxis or nasal fractures ( over 18 years)
You may not qualify if:
- laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist Trainee in ENT Surgery
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 21, 2020
Study Start
May 1, 2018
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
February 21, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share