The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures

NCT ID: NCT04279288

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-08-01

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.

Conditions

Epistaxis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

participants enrolled with epistaxis and/or nasal fractures

Group Type: EXPERIMENTAL

Hilotherm mask

Intervention Type: DEVICE

a cooling mask used to treat localized swelling and bleeding

Interventions

Hilotherm mask

a cooling mask used to treat localized swelling and bleeding

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Haroon Saeed

Specialist Trainee in ENT Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manchester University Hospitals NHS Foundation Trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

230638

Identifier Type: -

Identifier Source: org_study_id