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Taking people in Spanyolország4. fázis

General anesthesia versus sedation with high-flow nasal cannula for the endovascular treatment of acute ischemic stroke

Key facts

Where
Madrid, SpanyolországSee the site
Phase
4. fázis

Where in Spanyolország

  • Hospital Universitario La PazMadrid, SpanyolországTaking people

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Trial details

Who runs it
Hospital Universitario La Paz
Trial code
EU 2024-510752-12-00
Record updated
2024. szeptember 10.
Original description
The primary objective of the study is to assess the time from hospital arrival to revascularization in patients with acute ischemic stroke treated with mechanical thrombectomy, depending on whether the procedure was performed under sedation with HFNC or under general anesthesia.Read full original descriptionShow less

General anesthesia versus sedation with high-flow nasal cannula for the endovascular treatment of acute ischemic stroke. GHIFTS Study (General anesthesia vs High Flow nasal cannula for Thrombectomy on Stroke)

The primary objective of the study is to assess the time from hospital arrival to revascularization in patients with acute ischemic stroke treated with mechanical thrombectomy, depending on whether the procedure was performed under sedation with HFNC or under general anesthesia.

Inclusion: Age greater than or equal to 18 years; NIHSS ≥ 6 and ≤ 25; Anterior circulation stroke with isolated or combined occlusion of: - Intracranial Internal Carotid Artery. - Middle Cerebral Artery in its M1 or M2 segments; Time of evolution from clinical onset to radiology ward admission < 6 hours, or < 24 hours since last seen asymptomatic if salvageable tissue is demonstrated on neuroimaging tests; Informed consent signed by the patient if capable, or by a family member/legal representative if the patient is not capable.

Exclusion: Recent maxillofacial trauma/surgery; Failure to comply with fasting (6 hours of solids and 2 hours of clear liquids); Allergy or intolerance to any of the medications used for sedation or general anesthesia; Acute cerebral hemorrhage or clear hemorrhagic transformation in the same vascular territory; Coma on admission (Glasgow Coma Scale < 8); Baseline severe dependency status (mRS>3); Severe/significant agitation on admission; Objective loss of airway protection reflexes or vomiting on admission; Known or suspected difficult airway on examination; Thrombopenia <50,000 or severe coagulation disturbances.

EU CTIS 2024-510752-12-00