Acute Ischemic Stroke Clinical Trial
— EDESTROKEOfficial title:
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
Status | Recruiting |
Enrollment | 174 |
Est. completion date | December 31, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | University Clinical Hospital of Santiago de Compostela | Santiago de Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinico Universitario de Santiago |
Spain,
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. — View 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; — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Hospital length of stay | Duration in days of hospital stay | Approximately 3-15 days post procedure | |
Secondary | Intensive Care Unit length of stay | Duration in days of ICU stay | Approximately 1-15 days post procedure | |
Secondary | Patients extubated in the assigned group | Percentage of patients who can be extubated in the assigned group | Post procedure within 24 hours | |
Secondary | Number of patients with ICU complications | Complications: Pneumonia, sepsis, bacteraemia, tracheostomy, bronchial aspiration, others | Approximately 1-10 days post procedure | |
Secondary | Number of patients with complications associated with mechanical ventilation | Complications: Pneumonia, pneumothorax, respiratory distress, others | Approximately 1-10 days post procedure | |
Secondary | Number of patients with Hospital complications | Complications: Pneumonia, sepsis, others | Approximately 1-15 days post procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06113848 -
Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy
|
Phase 3 | |
Completed |
NCT04069546 -
The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
|
N/A | |
Active, not recruiting |
NCT05700097 -
Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy
|
Phase 2 | |
Recruiting |
NCT06058130 -
Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
|
N/A | |
Recruiting |
NCT04415164 -
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
|
Phase 4 | |
Recruiting |
NCT05363397 -
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
|
Phase 2 | |
Completed |
NCT05429658 -
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
|
N/A | |
Recruiting |
NCT05390580 -
Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
|
N/A | |
Enrolling by invitation |
NCT05515393 -
A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
|
Phase 2 | |
Active, not recruiting |
NCT05070260 -
ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo
|
Phase 2/Phase 3 | |
Terminated |
NCT05547412 -
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
|
||
Completed |
NCT03366818 -
New Stent Retriever, VERSI System for AIS
|
N/A | |
Not yet recruiting |
NCT06040476 -
Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)
|
Phase 2 | |
Not yet recruiting |
NCT05293080 -
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
|
Phase 3 | |
Not yet recruiting |
NCT06437431 -
Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy
|
Phase 2/Phase 3 | |
Completed |
NCT02223273 -
Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)
|
N/A | |
Completed |
NCT02586233 -
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01594190 -
Physical Activity Immediately After Acute Cerebral Ischemia
|
N/A | |
Terminated |
NCT01694381 -
Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor
|
Early Phase 1 | |
Completed |
NCT01120301 -
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
|
Phase 3 |