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Taking people in SpainPhase 4

Compares two ways of keeping patients calm during stroke clot removal

Compares sedation with high-flow oxygen to general anesthesia in adults with ischemic stroke.

Key facts

Who runs it
Hospital Universitario La Paz
Where
Madrid, SpainSee the site
Registry title
General anesthesia versus sedation with high-flow nasal cannula for the endovascular treatment of acute ischemic stroke
Status
Recruiting
Phase
Phase 4
People taking part
116 people, planned
Started
13 Nov 2024
Expected to end
1 Oct 2027
Type of study
Interventional
Record updated
10 September 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having a stroke caused by a blocked brain artery, who are treated by removing the clot through a catheter (mechanical thrombectomy). It compares sedation with a high-flow nasal cannula against general anesthesia.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Stroke in the front part of the brain circulation, with a blocked internal carotid artery or middle cerebral artery (M1 or M2). Stroke severity score (NIHSS) from 6 to 25. Less than 6 hours from first symptoms to arrival at the radiology ward, or less than 24 hours since last seen without symptoms if salvageable brain tissue is shown on imaging.

Main reasons for not taking part

  • Coma on admission (Glasgow Coma Scale below 8)
  • Severe dependency before the stroke (mRS above 3)
  • Severe agitation, or loss of airway protection reflexes or vomiting on admission
  • Known or suspected difficult airway, or fasting not kept (6 hours of solids, 2 hours of clear liquids)
  • Brain bleeding, platelets below 50,000, or severe blood clotting problems

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Spain

  • Hospital Universitario La PazMadrid, SpainTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Compares two ways of keeping patients calm during stroke clot removalGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
10 September 2024