Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

Официальное название

Migraine and High Flow Oxygenotherapy at the Emergency Department

Обзор

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits. Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine. However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc. In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient. In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Подробное описание

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.

Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.

However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.

In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.

In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Вмешательства

• Препарат oxygenotherapy
  High concentration mask delivering 15L/min of oxygen
• Препарат placebo air aerosol
  High concentration mask delivering 15L/min of air

Первичные конечные точки

• Pain evaluation [Срок оценки: 30 minutes after aerosol started]

Вторичные конечные точки (5)

• Associated symptoms resolution [Срок оценки: From aerosol start to 90 minutes after]
• Assess pain level [Срок оценки: From 30 minutes after aerosol start to 90 minutes after]
• Occurrence of side effects [Срок оценки: From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours]
• Assessing time spent in emergencies [Срок оценки: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours]
• Rescue analgesics usage [Срок оценки: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours]

Критерии участия

Критерии включения

• 18 years old or more
• Affiliated to a french public health insurance
• ED admission for migraine evocative headache, regarding ICHD3 criterions
• written informed consent

Критерии исключения

• COPD or other chronic respiratory failure conditions
• Pregnant or breastfeeding women or women of childbearing potential not using any means of contraception. A pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
• Under legal protection
• Patients who have received treatment with triptan in the past 2 weeks
• Patients who have consumed NSAIDs in the hour before the doctor's examination
• State of migraine headache (crippling attack for more than 72 hours)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Nice — Nice

Идентификаторы

NCT: NCT04925414 · 20-AOI-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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