Early vs Delayed Extubation After Endovascular Treatment for Acute Ischemic Stroke (EDESTROKE)

Optimal Ventilation Time After Endovascular Treatment Under General Anesthesia for Acute Ischemic Stroke. A Prospective, Randomized Comparison Between Early vs Delayed Extubation

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

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Endovascular Treatment
• Intervention / Treatment: Other: Early extubation; Other: Delayed extubation

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).

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15866
      • University Clinical Hospital of Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early extubation; Patients randomized to early extubation, will be extubated < 6 hours after endovascular treatment under general anesthesia.	Other: Early extubation; Patients randomized to early extubation, will be extubated < 6 hours after endovascular treatment under general anesthesia.
Experimental: Delayed extubation; Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.	Other: Delayed extubation; Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS (National Institutes of Health Stroke Scale)	Change in NIHSS score on day 1 and at the time of hospital discharge compared to admission to hospital. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. NIHSS score of 42 is the worst score (severe stroke), NIHSS score of 0 is "No stroke symptoms". 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke	Approximately 1-15 days post procedure
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 the time of hospital discharge 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	Approximately 3-15 days post procedure
Hospital length of stay	Duration in days of hospital stay	Approximately 3-15 days post procedure
Intensive Care Unit length of stay	Duration in days of ICU stay	Approximately 1-15 days post procedure
Patients extubated in the assigned group	Percentage of patients who can be extubated in the assigned group	Post procedure within 24 hours
Number of patients with ICU complications	Complications: Pneumonia, sepsis, bacteraemia, tracheostomy, bronchial aspiration, others	Approximately 1-10 days post procedure
Number of patients with complications associated with mechanical ventilation	Complications: Pneumonia, pneumothorax, respiratory distress, others	Approximately 1-10 days post procedure
Number of patients with Hospital complications	Complications: Pneumonia, sepsis, others	Approximately 1-15 days post procedure

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago
• Investigators: Principal Investigator: Manuel Taboada, Ph.D., Clinical University Hospital of Santiago de Compostela; Principal Investigator: Manuel Rodríguez, M.D., Clinical University Hospital of Santiago de Compostela

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; Stroke; endovascular treatment; functional status; Extubation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: EDESTROKE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support
• IPD Sharing Time Frame: When available: With publication
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No