The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The Investigators aimed to assess primarily whether or not Hilotherapy masks are a tolerable treatment for the conservative management of epistaxis and nasal fractures.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presenting to ED with epistaxis or nasal fractures ( over 18 years)
排除标准
- •laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
Haroon Saeed
Specialist Trainee in ENT Surgery
Manchester University NHS Foundation Trust
