NCT06224426

Oxygen Concentration Target in Stroke Endovascular Treatment

Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * Evaluating the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function after EVT. * Evaluating the safety of high and low normobaric oxygen concentration in patients with ischemic stroke. Participants will (1) receive EVT under general anesthesia; (2) be randomly assigned 1:1 to receive oxygen therapy with FiO2=80% or FiO2=30% through endotracheal intubation during the operation, and the gas flow rate was set at 4L /min.

Detailed description

The optimal fraction of inspired oxygen (FiO2) during EVT under general anesthesia is currently uncertain. This is a randomized controlled trial (RCT) designed to assess the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function following EVT. It is a prospective, open-label, parallel-design RCT planned to be conducted at Beijing Tiantan Hospital, Capital Medical University. It is anticipated that 200 cases of AIS patients undergoing EVT under general anesthesia will be consecutively enrolled from 2024 to 2026. Eligible participants will be randomly assigned in a 1:1 ratio. After general anesthesia induction, patients will receive continuous inhalation of oxygen with either FiO2=80% or FiO2=30% through endotracheal intubation until the end of the procedure, with a gas flow rate set at 4 L/min. The positive end-expiratory pressure (PEEP) is uniformly set to 5 cmH2O to balance its effect on pulmonary oxygen delivery. The primary outcome will be the occurrence of early neurological improvement (NIHSS score of 10 points 24±2 hours after EVT). Safety outcomes include potential adverse events such as site infection, three-month mortality, etc.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Normobaric high-concentration oxygen	During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min.
OTHER	Normobaric low-concentration oxygen	During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-01-25
• Last updated: 2024-12-02

Locations

1 site across 1 country: China