2024-510752-12-00RecruitingPhase 4
General anesthesia versus sedation with high-flow nasal cannula for the endovascular treatment of acute ischemic stroke
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 13 Nov 2024
- Lead sponsor
- Hospital Universitario La Paz
- Diseases
- Stroke
- EU CT number
- 2024-510752-12-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 116
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent maxillofacial trauma/surgery.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.