Early vs Delayed Extubation After Endovascular Treatment for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— EDESTROKE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847309
• Other study ID #: EDESTROKE
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: Manuel Taboada, Ph.D.
• Phone: 0034981950674
• Email: manutabo[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Endovascular Treatment
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Delayed extubation
Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.
• Early extubation
Patients randomized to early extubation, will be extubated < 6 hours after endovascular treatment under general anesthesia.

Locations

Country	Name	City	State
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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

Outcome

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