Oxygen Concentration Target in Stroke Endovascular Treatment

Ischemic Stroke Clinical Trial

— Oxy-TARGET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224426
• Other study ID #: zkd20231121
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, Ph.D
• Phone: +86 13701285393
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• 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:

• Age =18 years.

• Anterior circulation occlusive stroke was confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), and occlusions of the terminal internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA) were involved.

• NIHSS score at admission: 6-25.

Exclusion Criteria:

• Stroke onset at 6-24 hours with a mismatched area < 15 ml was assessed by CT perfusion imaging (CTP).

• Significant dysfunction before stroke was defined as a modified Rankin scale (mRS) score =2.

• The condition was complicated by severe agitation and seizures.

• Evidence of intracranial hemorrhage at admission.

• Pulmonary disease complicated by impaired gas exchange.

• An oxygen mask or ventilator must be used before anesthesia to maintain a SpO2=94%.

• Loss of airway protective reflex or vomiting aspiration upon admission.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	symptomatic ICH	defined as the presence of hemorrhage on CT at 24±12 h accompanied by an NIHSS score increase=4	24±12 hours after EVT
Other	all-cause mortality at 90 days	deaths from any cause during the 3-month follow-up period	90 days after stroke onset
Other	stroke-related death	typically defined as death directly attributable to the stroke and its complications, encompassing but not limited to severe cerebral edema, brain herniation, infections, cardiac diseases, pulmonary embolism, and deep vein thrombosis occurring during the acute phase of AIS	within 7 days after endovascular therapy
Other	Postoperative baseline PaCO2	Arterial partial oxygen pressure based on arterial blood gas	From the end of the intervention procedure until the time just before the tracheal tube is removed.
Other	Postoperative baseline oxygenation index	oxygenation index=PaCO2/FiO2	From the end of the intervention procedure until the time just before the tracheal tube is removed.
Primary	the incidence of early neurological improvement (ENI)	ENI is defined as an NIHSS score of <10 points at 24±2 hours after EVT	24±2 hours after EVT
Secondary	?NIHSS at 24±2 hours after EVT	baseline NIHSS score - NIHSS score at 24±2 h	24±2 hours after EVT
Secondary	overall mRS distribution at 90 days	modified Rankin scale (mRS) scores are distributed between 0 and 6	90 days after stroke onset
Secondary	favorable functional outcome	an mRS score of 0-2 at 90 days	90 days after stroke onset
Secondary	early neurological deterioration (END)	an increase of =4 from the baseline NIHSS score on day 1 after reperfusion therapy in AIS patients	1 day after reperfusion therapy
Secondary	Postoperative pulmonary complications	defined as a composite measure encompassing pulmonary infections, atelectasis, pleural effusion, respiratory failure, bronchospasm, and pneumothorax	within 7 days after endovascular therapy