Acute Ischemic Stroke, Endovascular Treatment
Conditions
Keywords
Stroke, endovascular treatment, Extubation, mechanical ventilation, functional status
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).
Interventions
OTHERDelayed extubation
Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.
OTHEREarly extubation
Patients randomized to early extubation, will be extubated \< 6 hours after endovascular treatment under general anesthesia.
Sponsors
Hospital Clinico Universitario de Santiago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Intervention study, prospective, randomized, parallel and blind for the end point evaluators. (Prospective Randomized, Blinded End-point))
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ranking Scale (mRS) | 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS (National Institutes of Health Stroke Scale) | Approximately 1-15 days post procedure | 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 |
| Modified Ranking Scale (mRS) | Approximately 3-15 days post procedure | 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 |
| Hospital length of stay | Approximately 3-15 days post procedure | Duration in days of hospital stay |
| Intensive Care Unit length of stay | Approximately 1-15 days post procedure | Duration in days of ICU stay |
| Patients extubated in the assigned group | Post procedure within 24 hours | Percentage of patients who can be extubated in the assigned group |
| Number of patients with ICU complications | Approximately 1-10 days post procedure | Complications: Pneumonia, sepsis, bacteraemia, tracheostomy, bronchial aspiration, others |
| Number of patients with complications associated with mechanical ventilation | Approximately 1-10 days post procedure | Complications: Pneumonia, pneumothorax, respiratory distress, others |
| Number of patients with Hospital complications | Approximately 1-15 days post procedure | Complications: Pneumonia, sepsis, others |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORManuel Taboada, Ph.D.
Clinical University Hospital of Santiago de Compostela
PRINCIPAL_INVESTIGATORManuel Rodríguez, M.D.
Clinical University Hospital of Santiago de Compostela
Outcome results
None listed