Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oxygenotherapy, placebo air aerosol.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Migraine and High Flow Oxygenotherapy at the Emergency Department
Overview
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.
Detailed description
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.
Interventions
- Drug oxygenotherapy
High concentration mask delivering 15L/min of oxygen - Drug placebo air aerosol
High concentration mask delivering 15L/min of air
Primary outcome measures
- Pain evaluation [Time frame: 30 minutes after aerosol started]
Secondary outcome measures (5)
- Associated symptoms resolution [Time frame: From aerosol start to 90 minutes after]
- Assess pain level [Time frame: From 30 minutes after aerosol start to 90 minutes after]
- Occurrence of side effects [Time frame: From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours]
- Assessing time spent in emergencies [Time frame: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours]
- Rescue analgesics usage [Time frame: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours]
Eligibility criteria
Inclusion criteria
- 18 years old or more
- Affiliated to a french public health insurance
- ED admission for migraine evocative headache, regarding ICHD3 criterions
- written informed consent
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT04925414 · 20-AOI-08