EpistaxisNCT04279288
The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
A study testing Hilotherm mask in people with Epistaxis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- Hilotherm mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting to ED with epistaxis or nasal fractures ( over 18 years)
Who cannot join
- laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University Hospitals NHS Foundation Trust
Manchester
About this study
The Investigators aimed to assess primarily whether or not Hilotherapy masks are a tolerable treatment for the conservative management of epistaxis and nasal fractures.
Read the 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.
- Conditions
- Epistaxis
- Being tested
- Hilotherm mask
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hilotherm maskDevice
a cooling mask used to treat localized swelling and bleeding
| Study group | Role | What they receive |
|---|---|---|
| participants enrolled with epistaxis and/or nasal fractures | Experimental | Not described Receives: Device: Hilotherm mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: within 20 minutes of mask application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 May 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haroon Saeed, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279288
- Sponsor's protocol ID
- 230638
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
- ClinicalTrials.gov ID
- NCT04279288
- Acronym / sponsor ID
- 230638
- Conditions
- Epistaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants enrolled with epistaxis and/or nasal fractures | Experimental | Device: Hilotherm mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presenting to ED with epistaxis or nasal fractures ( over 18 years)
Key exclusion criteria (1 listed)
- laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hilotherm maska cooling mask used to treat localized swelling and bleeding | Device | participants enrolled with epistaxis and/or nasal fractures |
Primary outcome
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.
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.
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.
1 secondary outcome
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.
Time frame: within 20 minutes of mask application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hilotherm mask in people with Epistaxis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.