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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early extubation | Active Comparator | Patients randomized to early extubation, will be extubated < 6 hours after endovascular treatment under general anesthesia. |
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| Delayed extubation | Experimental | Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed extubation | Other | Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Taboada, Ph.D. | Clinical University Hospital of Santiago de Compostela | Principal Investigator |
| Manuel RodrÃguez, M.D. | Clinical University Hospital of Santiago de Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital of Santiago de Compostela | Santiago de Compostela | A Coruña | 15866 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26822729 | Background | 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. | |
| 10806150 |
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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
When available: With publication
Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Intervention study, prospective, randomized, parallel and blind for the end point evaluators. (Prospective Randomized, Blinded End-point))
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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.
| Early extubation | Other | Patients randomized to early extubation, will be extubated < 6 hours after endovascular treatment under general anesthesia. |
|
| 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 |
| 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. |
| 32065457 | Result | 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. |
| 41910960 | Derived | 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 May 1;83(5):481-489. doi: 10.1001/jamaneurol.2026.0475. |
| 38835061 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |