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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
174
Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.
Patients randomized to early extubation, will be extubated \< 6 hours after endovascular treatment under general anesthesia.
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
RECRUITINGModified 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
Time frame: 90 days
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
Time frame: 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
Time frame: Approximately 3-15 days post procedure
Hospital length of stay
Duration in days of hospital stay
Time frame: Approximately 3-15 days post procedure
Intensive Care Unit length of stay
Duration in days of ICU stay
Time frame: Approximately 1-15 days post procedure
Patients extubated in the assigned group
Percentage of patients who can be extubated in the assigned group
Time frame: Post procedure within 24 hours
Number of patients with ICU complications
Complications: Pneumonia, sepsis, bacteraemia, tracheostomy, bronchial aspiration, others
Time frame: Approximately 1-10 days post procedure
Number of patients with complications associated with mechanical ventilation
Complications: Pneumonia, pneumothorax, respiratory distress, others
Time frame: Approximately 1-10 days post procedure
Number of patients with Hospital complications
Complications: Pneumonia, sepsis, others
Time frame: Approximately 1-15 days post procedure
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