The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
Primary Purpose
Epistaxis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hilotherm mask
Sponsored by
About this trial
This is an interventional treatment trial for Epistaxis
Eligibility Criteria
Inclusion Criteria:
- presenting to ED with epistaxis or nasal fractures ( over 18 years)
Exclusion Criteria:
- laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
Sites / Locations
- Manchester University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
participants enrolled with epistaxis and/or nasal fractures
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Cessation of epistaxis was initially measured by an ENT clinician after 20 minutes of mask application. If the rate of epistaxis had reduced or the epistaxis had stopped the mask was applied for a further 20 minutes. Assessing if the epistaxis had reduced was a subjective measure, which as not based on any definable scale or units. It was depended upon the ENT doctors initial assessment of the bleeding and the resulting change in visible flow of blood from the nose after the mask had been applied. If the epistaxis has stopped this was visually defined and recorded as complete cessation of bleeding from the nose and posteriorly into the oropharynx.
Full Information
NCT ID
NCT04279288
First Posted
February 11, 2020
Last Updated
February 18, 2020
Sponsor
Manchester University NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04279288
Brief Title
The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
Official Title
The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manchester University NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants who had ongoing epistaxis and met the inclusion criteria where enrolled in the pilot study . Bleeding severity was not recorded. All participants enrolled were clinically stable with active epistaxis. Participants who were unstable or were ineligible were not referred to the recruiting doctors by A&E triage. Following informed consent the Hilotherm mask was fitted for an initial period of 20 minutes. If the bleeding had improved or stopped following 20 minutes of treatment the Hilotherm mask remained fitted for a 20 further minutes . A subjective decision was made by the supervising doctor and the participant to whether the flow of epistaxis had improved after the initial 20 minutes of hilotherapy.
The mask was removed if there was no improvement after the initial 20 minutes of hilotherapy, 40 minutes of total hilotherapy treatment, participant preference, worsening observations or profuse bleeding. Participants received conventional epistaxis management simultaneously, this involved continued nasal pressure application during hilotherapy. Following hilotherapy if epistaxis continued then either nasal cauterisation or packing was performed. Participants who were packed cessation of epistaxis was determined at the time of packing if bleeding had ceased. Bleeding time was accurately assessed by the recruiting doctor from the time of hilotherm mask application to the time of complete epistaxis cessation. All of the participants were treated in the sitting position.
Participants were free to withdraw from the trial at any time and no further data was analysed from the individual. Clinicians recorded anticoagulant and antiplatelet use, duration of bleeding and patient demographics. All participants completed a questionnaire following their hilotherapy treatment independantly.
A similar protocol was devised for nasal fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
participants enrolled with epistaxis and/or nasal fractures
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hilotherm mask
Intervention Description
a cooling mask used to treat localized swelling and bleeding
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
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 Outcome Measure Information:
Title
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.
Description
Cessation of epistaxis was initially measured by an ENT clinician after 20 minutes of mask application. If the rate of epistaxis had reduced or the epistaxis had stopped the mask was applied for a further 20 minutes. Assessing if the epistaxis had reduced was a subjective measure, which as not based on any definable scale or units. It was depended upon the ENT doctors initial assessment of the bleeding and the resulting change in visible flow of blood from the nose after the mask had been applied. If the epistaxis has stopped this was visually defined and recorded as complete cessation of bleeding from the nose and posteriorly into the oropharynx.
Time Frame
within 20 minutes of mask application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
presenting to ED with epistaxis or nasal fractures ( over 18 years)
Exclusion Criteria:
laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
Facility Information:
Facility Name
Manchester University Hospitals NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
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