Early Vs Delayed Extubation After Endovascular Treatment for Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2026-12-31

Brief Summary

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Although older studies, most of them retrospective in design, advocated sedation over general anesthesia during endovascular treatment for acute ischemic stroke, a recent meta-analysis and randomized studies have shown that general anesthesia is associated with better functional status at 3 months compared with local anesthesia and sedation. In our center, most procedures are performed under general anesthesia, and once the procedure is complete, the patient is transferred intubated and sedated to the ICU. If the patient is hemodynamically and respiratory stable, the patient will be extubated, and will be discharged to the Neurology hospitalization floor.

Several factors have been described that may influence the evolution and functional status at three months of patients who have suffered a stroke and have received endovascular treatment, such as the time between the onset of symptoms and admission to the ward for performing the procedure, the use of general anesthesia compared to sedation and local anesthesia, adequate control of blood pressure, the size of the cerebral infarct, or a worse neurological examination at the time of the procedure. In turn, several factors have been described that may influence the success of extubation in a patient who has suffered an acute ischemic stroke and who has required orotracheal intubation, such as the absence of dysarthria, the size of the infarct, the location of the infarction, the NIHSS (National Institutes of health Stroke Scale) or neurological status prior to orotracheal intubation. The investigators do not know, however, whether the time of mechanical ventilation can influence the evolution and functional status at three months of patients who have suffered a stroke and have received endovascular treatment under general anesthesia

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Detailed Description

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The authors do not know whether the time of mechanical ventilation can influence the evolution and functional status at three months of patients who have suffered a stroke and have received endovascular treatment under general anesthesia. The purpose of this prospective randomized study is to compare the neurological functional status at 3 months according to the modified Rankin scale (mRS), of patients with stroke who underwent endovascular intervention with satisfactory results and who underwent early extubation (\< 6 hours) compared to delayed extubation (6-12 hours).

Conditions

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Acute Ischemic Stroke Endovascular Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention study, prospective, randomized, parallel and blind for the end point evaluators. (Prospective Randomized, Blinded End-point))

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

We will compare patients extubated before 6 hours and between 6 to 12 hours after endovascular treatment with general anesthesia for stroke. The patient will not know the hours that he was on mechanical ventilation (masking participant). Investigators evaluating the primary endpoint (mRS at three months) and other secondary endpoints will not know to which group they were randomized. Only the research physicians who treat the patient in the ICU during the first 24 hours know the assigned group.

Study Groups

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Early extubation

Patients randomized to early extubation, will be extubated \< 6 hours after endovascular treatment under general anesthesia.

Group Type ACTIVE_COMPARATOR

Early extubation

Intervention Type OTHER

Patients randomized to early extubation, will be extubated \< 6 hours after endovascular treatment under general anesthesia.

Delayed extubation

Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.

Group Type EXPERIMENTAL

Delayed extubation

Intervention Type OTHER

Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.

Interventions

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Delayed extubation

Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.

Intervention Type OTHER

Early extubation

Patients randomized to early extubation, will be extubated \< 6 hours after endovascular treatment under general anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult (age ≥ 18 years)
* Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations (occlusion of the internal carotid artery and/or middle cerebral artery in segments M1, M2, M3) within 24 hours of symptom onset.
* Patients admitted with a NIHSS neurological status ≥ 6.
* Patients who received endovascular treatment under general anesthesia (intubated in the interventional radiology room) with satisfactory reperfusion (TICI 2b-2c-3).
* Patients admitted in the intensive care unit (ICU) with mechanical ventilation.
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria

* Patients who have not been intubated in the interventional radiology room.
* Pregnancy
* Patients who suffer bronchial aspiration prior to the endovascular procedure or during intubation.
* Patients who underwent the procedure under local anesthesia and sedation.
* Patients with functional neurological status, prior to the ischemic stroke, measured with the modified Rankin scale (mRS) of value: 3-6.
* Patients with vascular involvement of the posterior cerebral circulation, or intracranial haemorrhage associated with stroke.
* Patients who do not sign the informed consent by themselves or their relatives.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No