Clinical trial NCT05847309: Early Vs Delayed Extubation After Endovascular Treatment for Acute Ischemic Stroke
Official title: Optimal Ventilation Time After Endovascular Treatment Under General Anesthesia for Acute Ischemic Stroke. a Prospective, Randomized Comparison Between Early Vs Delayed Extubation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Endovascular Treatment
Keywords: Stroke
endovascular treatment
Extubation
mechanical ventilation
functional status
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention study, prospective, randomized, parallel and blind for the end point evaluators. (Prospective Randomized, Blinded End-point))
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Ranking Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: NIHSS (National Institutes of Health Stroke Scale)
timeFrame: Approximately 1-15 days post procedure
measure: Modified Ranking Scale (mRS)
timeFrame: Approximately 3-15 days post procedure
measure: Hospital length of stay
timeFrame: Approximately 3-15 days post procedure
measure: Intensive Care Unit length of stay
timeFrame: Approximately 1-15 days post procedure
measure: Patients extubated in the assigned group
timeFrame: Post procedure within 24 hours
measure: Number of patients with ICU complications
timeFrame: Approximately 1-10 days post procedure
measure: Number of patients with complications associated with mechanical ventilation
timeFrame: Approximately 1-10 days post procedure
measure: Number of patients with Hospital complications
timeFrame: Approximately 1-15 days post procedure
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University Clinical Hospital of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: Clinical University Hospital of Santiago de Compostela
name: Manuel Taboada, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical University Hospital of Santiago de Compostela
name: Manuel Rodríguez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fandler-Hofler S, Heschl S, Kneihsl M, Arguelles-Delgado P, Niederkorn K, Pichler A, Deutschmann H, Fazekas F, Berghold A, Enzinger C, Gattringer T. Ventilation time and prognosis after stroke thrombectomy: the shorter, the better! Eur J Neurol. 2020 May;27(5):849-855. doi: 10.1111/ene.14178. Epub 2020 Mar 17.
citation: Nikoubashman O, Schurmann K, Probst T, Muller M, Alt JP, Othman AE, Tauber S, Wiesmann M, Reich A. Clinical Impact of Ventilation Duration in Patients with Stroke Undergoing Interventional Treatment under General Anesthesia: The Shorter the Better? AJNR Am J Neuroradiol. 2016 Jun;37(6):1074-9. doi: 10.3174/ajnr.A4680. Epub 2016 Jan 28.
citation: Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.