Testing Two Oxygen Levels During Stroke Clot Removal Surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having a stroke caused by a blocked artery in the front part of the brain, who are getting clot-removal treatment (endovascular therapy). It compares two oxygen levels given during the operation.

Age

18 years or older.

Sex

All sexes can join.

Disease stage

Blockage of a large artery in the front of the brain (internal carotid artery or the M1 part of the middle cerebral artery), confirmed by CTA, MRA or DSA. NIHSS score at admission 6-20. Randomization within 24 hours after stroke onset.

Main reasons for not taking part

• Bleeding in the brain at admission
• Lung disease such as COPD or asthma, or need for daily extra oxygen or a ventilator
• Anemia (hemoglobin below 120 g/L in men and below 110 g/L in women)
• Before the stroke, mRS score of 2 or more
• Poor gas exchange in the lungs, or signs of a significant lung infection on chest CT

The registry criteria, word for word

What the trial wants to find out

The goal of this clinical trial is to compare the effects of different concentrations of normobaric oxygen on early neurological improvement in acute ischemic stroke (AIS) patients receiving endovascular therapy (EVT). The main questions it aims to answer are:

The 2 groups in the trial

• Normobaric high-concentration oxygen (NBHO) groupTreatment being tested

  After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBHO group will adjust the FiO2 at 80% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.

  Treatment: Normobaric high-concentration oxygen

• Normobaric low-concentration oxygen (NBLO) groupTreatment being tested

  After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBLO group will adjust the FiO2 at 30% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.

  Treatment: Normobaric low-concentration oxygen