Oxygen Concentration Target in Stroke Endovascular Treatment

NCT06224426 | Recruiting DMC

• 1 other identifier: zkd20231121
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

Endovascular therapy; Acute ischemic stroke; Normobaric hyperoxia; Early neurological improvement; General anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• ΔNIHSS at 24±2 hours after EVT

  24±2 hours after EVT

• the final infarct volume

  72 hours post-randomization

• early neurological deterioration (END)

  1 day after reperfusion therapy

• Postoperative pulmonary complications

  within 7 days after endovascular therapy

• overall mRS distribution at 90 days

  90 days after stroke onset

Other Outcomes (5)

• Postoperative baseline PaO2

  From the end of the intervention procedure until the time just before the tracheal tube is removed.

• Postoperative baseline oxygenation index

  From the end of the intervention procedure until the time just before the tracheal tube is removed.

• symptomatic ICH

  24±12 hours after EVT

Study Arms (2)

Normobaric high-concentration oxygen (NBHO) group

EXPERIMENTAL

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.

Other: Normobaric high-concentration oxygen

Normobaric low-concentration oxygen (NBLO) group

EXPERIMENTAL

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.

Other: Normobaric low-concentration oxygen

Interventions

Normobaric high-concentration oxygen OTHER

During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min.

Normobaric high-concentration oxygen (NBHO) group

Normobaric low-concentration oxygen OTHER

During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.

Normobaric low-concentration oxygen (NBLO) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Anterior circulation occlusive stroke is confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), and occlusions of intracranial internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA) were involved.
• NIHSS score at admission: 6-20.
• Randomization can be completed within 24 hours after stroke onset.

You may not qualify if:

• Stroke onset within 6-24 hours with a CT perfusion imaging (CTP)-assessed mismatched area\<15 ml.
• Presence of anemia, defined as hemoglobin levels o below 120 g/L in men and below 110 g/L in women.
• Pre-stroke modified Rankin scale (mRS) score ≥2.
• Complicated by severe agitation and seizures.
• Evidence of intracranial hemorrhage at admission.
• Presence of chronic obstructive pulmonary disease, asthma, or other respiratory conditions, or requirement for daily supplemental oxygen or mechanical ventilation.
• Baseline arterial blood gas analysis indicating impaired gas exchange: PaO2 \< 60 mmHg on room air, or oxygenation index (PaO2/FiO2) \< 300 mmHg with supplemental oxygen.
• Emergency chest CT reveals significant pulmonary parenchymal infection.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

• Hu Z, Zhang K, Wu Y, Wang X, Zhang Z, Hou X, Jian M, Wang Y, Liu H, Wang A, Han R, Liang F. Oxygenation targets for endovascular therapy in acute ischemic stroke patients (Oxy-TARGET): protocol for a single-centre, open-label randomised controlled trial. BMJ Open. 2025 Jan 4;15(1):e086234. doi: 10.1136/bmjopen-2024-086234.

  PMID: 39755573 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ruquan Han, Ph.D

  Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University

  STUDY DIRECTOR

Central Study Contacts

Ruquan Han, Ph.D

CONTACT

+86 13701285393; ruquan.han@ccmu.edu.cn

Zhengfang Hu, M.D

CONTACT

+86 13041084927; huzhengfang78@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 25, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)