Early vs Delayed Extubation After Endovascular Treatment for Acute Ischemic Stroke

NCT05847309 | Completed

• 1 other identifier: EDESTROKE
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Ischemic Stroke; Endovascular Treatment

Keywords

Stroke; endovascular treatment; Extubation; mechanical ventilation; functional status

Outcome Measures

Primary Outcomes (1)

• Modified Ranking Scale (mRS)

  Comparison of independent functional outcome as measured by the percentage of patients with a 0 to 2 on the modified Rankin Scale (mRS) at 90 days assessed by study personal blinded to the treatment (early vs delayed extubation) The scale of mRS is 0 to 6. The best neurological outcome is the mRS with 0, indicating no any symptom left, and a good neurological outcome is agreed with a mRS 0 to 2. mRS of 6 is the worst, indicating death. mRS will be evaluated by outcome assessor who is blinded to the group

  90 days

Secondary Outcomes (8)

• NIHSS (National Institutes of Health Stroke Scale)

  Approximately 1-15 days post procedure

• Modified Ranking Scale (mRS)

  Approximately 3-15 days post procedure

• Hospital length of stay

  Approximately 3-15 days post procedure

• Intensive Care Unit length of stay

  Approximately 1-15 days post procedure

• Patients extubated in the assigned group

  Post procedure within 24 hours

Study Arms (2)

Early extubation

ACTIVE COMPARATOR

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

Other: Early extubation

Delayed extubation

EXPERIMENTAL

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

Other: Delayed extubation

Interventions

Delayed extubation OTHER

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

Delayed extubation

Early extubation OTHER

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

Early extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

Location

Related Publications (5)

• 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.

  PMID: 26822729 BACKGROUND

• 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.

  PMID: 10806150 BACKGROUND

• 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.

  PMID: 32065457 RESULT

• Taboada M, Estany-Gestal A, Fernandez J, Dos Santos L, Barreiro L, Williams K, Cardalda-Serantes B, Lopez C, Mendez M, Rodriguez-Yanez M, Otero P, Naveira A, Caruezo V, Veiras S, San Luis E, Diaz-Vieito M, Arias-Rivas S, Santamaria-Cadavid M, Rodriguez-Castro E, Mosquera A, Castineiras JA, Vazquez F, Blanco M, Taboada JL, Muniategui I, Ferreiroa E, Carinena A, Tubio A, Campana O, Selas S, Aneiros F, Martinez A, Eiras M, Costa J, Prieto JM, Alvarez J, Seoane-Pillado T. Early vs Delayed Extubation After Thrombectomy for Acute Ischemic Stroke: The EDESTROKE Randomized Clinical Trial. JAMA Neurol. 2026 Mar 30. doi: 10.1001/jamaneurol.2026.0475. Online ahead of print.

  PMID: 41910960 DERIVED

• Taboada M, Estany-Gestal A, Fernandez J, Barreiro L, Williams K, Rodriguez-Yanez M, Otero P, Naveira A, Caruezo V, Veiras S, San Luis E, Dos Santos L, Diaz-Vieito M, Arias-Rivas S, Santamaria-Cadavid M, Rodriguez-Castro E, Vazquez F, Blanco M, Mosquera A, Castineiras JA, Muniategui I, Ferreiroa E, Carinena A, Tubio A, Campana O, Selas S, Aneiros F, Martinez A, Eiras M, Costa J, Prieto JM, Alvarez J. Effect of early vs. delayed extubation on functional outcome among patients with acute ischemic stroke treated with endovascular thrombectomy under general anesthesia: the prospective, randomized controlled EDESTROKE trial study protocol. Trials. 2024 Jun 4;25(1):357. doi: 10.1186/s13063-024-08181-y.

  PMID: 38835061 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manuel Taboada, Ph.D.

  Clinical University Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Manuel Rodríguez, M.D.

  Clinical University Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

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

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 6, 2023
• Study Start: April 18, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When available: With publication
• Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

Locations

ES (1)