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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario La Paz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

13 Nov 2024 → ongoing

Decision date (initial)

2024-08-14

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. To assess whether there are differences between the two groups in terms of clinical and functional outcome, assessed by the NIHSS scale at 24 hours and the modified Rankin scale (mRS) 90 days after stroke. The latter will be assessed by telephone or face-to-face interview.
2. To assess whether there are differences in other procedure times: door-arterial puncture, room entry-arterial puncture, arterial puncture-recanalization.
3. To analyze whether there are differences in the degree of arterial recanalization obtained after treatment, assessed using the modified treatment in cerebral infarction (mTICI) scale.
4. To assess whether there are differences in the incidence of complications during the intervention in both groups (arterial perforation, dissection, embolisms to new territories, complications at the point of arterial puncture, arterial hypertension or hypotension, arrhythmias, hypoxemia, and bronchial aspiration) as well as after the procedure (cerebral hemorrhage, hypertension or hypotension, arrhythmias, hypoxemia or pneumonia). Their presence will be assessed after 24 hours, and upon discharge from hospital.

Conditions and MedDRA coding

Acute ischemic stroke

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age greater than or equal to 18 years.
2. NIHSS ≥ 6 and ≤ 25.
3. Anterior circulation stroke with isolated or combined occlusion of: - Intracranial Internal Carotid Artery. - Middle Cerebral Artery in its M1 or M2 segments.
4. 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.
5. Informed consent signed by the patient if capable, or by a family member/legal representative if the patient is not capable.

Exclusion criteria 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time between arrival at the hospital door and arterial recanalization (in minutes). This time has been shown to be sensitive to the type of anesthetic procedure used in the different meta-analyses published and, in addition to including the time of the intervention, which may also be influenced by the anesthetic technique, it is less affected by other factors than other times collected for the assessment of stroke treatment, such as the time from onset of the clinic to recanalization.

Secondary endpoints 4

1. NIHSS scale at 24 hours and the modified Rankin scale (mRS) 90 days after stroke.
2. Door time - arterial puncture: minutes. Arterial puncture time - recanalization: minutes
3. Degree of arterial recanalization, according to the mTICI scale (modified Thrombolysis in Cerebral Infarction Scale): 0-3
4. Incidence of complications during the intervention in both groups (arterial perforation, dissection, embolisms to new territories, complications at the point of arterial puncture, arterial hypertension or hypotension, arrhythmias, hypoxemia, and bronchial aspiration) as well as after the procedure (cerebral hemorrhage, hypertension or hypotension, arrhythmias, hypoxemia or pneumonia). Their presence will be assessed after 24 hours, and upon discharge from hospital.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario La Paz

Sponsor organisation

Hospital Universitario La Paz

Address

Paseo Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Hospital Universitario La Paz

Contact name

Pedro Navia Álvarez

Public contact point

Organisation

Hospital Universitario La Paz

Contact name

Pedro Navia Álvarez

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications