Clinical trial NCT04279288: 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
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-02-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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.
timeFrame: 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:
measure: 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.
timeFrame: within 20 minutes of mask application
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University Hospitals NHS Foundation Trust
Study officials:
References: