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

Sponsor

Hospital Clinico Universitario de Santiago (Other)

Overall Status

Recruiting

CT.gov ID

NCT05847309

Collaborator

(none)

174

Enrollment

Location

Arms

44.8

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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, he will be extubated, and he 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

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Endovascular Treatment	Other: Delayed extubation Other: Early extubation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intervention study, prospective, randomized, parallel and blind for the end point evaluators. (Prospective Randomized, Blinded End-point))Intervention study, prospective, randomized, parallel and blind for the end point evaluators. (Prospective Randomized, Blinded End-point))

Masking:

Double (Participant, 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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 8, 2023

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña	Spain	15866

Sponsors and Collaborators

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