Ischemic StrokeOxy-TARGETNCT06224426
Oxygen Concentration Target in Stroke Endovascular Treatment
A study testing Normobaric high-concentration oxygen and Normobaric low-concentration oxygen in people with Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Normobaric high-concentration oxygen and Normobaric low-concentration oxygen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Ruquan Han, Ph.D, 86-13701285393, ruquan.han@ccmu.edu.cn
About this study
Official title: Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)
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.
Read the 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
- Being tested
- Normobaric high-concentration oxygen, Normobaric low-concentration oxygen
- Keywords
- Endovascular therapy, Acute ischemic stroke, Normobaric hyperoxia, Early neurological improvement, General anesthesia
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric high-concentration oxygenOther
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 oxygenOther
During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normobaric low-concentration oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of early neurological improvement (ENI)
ENI is defined as an NIHSS score of <10 points at 24±2 hours after EVT
Measured: 24±2 hours after EVT
Secondary outcomes (6)
ΔNIHSS at 24±2 hours after EVT
baseline NIHSS score - NIHSS score at 24±2 h
Measured: 24±2 hours after EVT
the final infarct volume
After collecting cranial CT images, the infarct volume was delineated using ITK-SNAP software.
Measured: 72 hours post-randomization
early neurological deterioration (END)
an increase of ≥4 from the baseline NIHSS score on day 1 after reperfusion therapy in AIS patients
Measured: 1 day after reperfusion therapy
Postoperative pulmonary complications
defined as a composite measure encompassing pulmonary infections, atelectasis, pleural effusion, respiratory failure, bronchospasm, and pneumothorax
Measured: within 7 days after endovascular therapy
overall mRS distribution at 90 days
modified Rankin scale (mRS) scores are distributed between 0 and 6
Measured: 90 days after stroke onset
favorable functional outcome
an mRS score of 0-2 at 90 days
Measured: 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Feb 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, Ph.D, Study director, Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224426
- Sponsor's protocol ID
- zkd20231121
- Acronym
- Oxy-TARGET
- Status last verified
- Feb 2024
- First submitted
- 17 Dec 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39755573
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)
- ClinicalTrials.gov ID
- NCT06224426
- Acronym / sponsor ID
- Oxy-TARGET / zkd20231121
- Conditions
- Ischemic Stroke
- Keywords
- Endovascular therapy, Acute ischemic stroke, Normobaric hyperoxia, Early neurological improvement, General anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normobaric high-concentration oxygen (NBHO) group | Experimental | Other: Normobaric high-concentration oxygenAfter 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. |
| Normobaric low-concentration oxygen (NBLO) group | Experimental | Other: Normobaric low-concentration oxygenAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normobaric high-concentration oxygenDuring endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min. | Other | Normobaric high-concentration oxygen (NBHO) group |
| Normobaric low-concentration oxygenDuring endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min. | Other | Normobaric low-concentration oxygen (NBLO) group |
Primary outcome
the incidence of early neurological improvement (ENI)
Time frame: 24±2 hours after EVT
ENI is defined as an NIHSS score of <10 points at 24±2 hours after EVT
6 secondary outcomes
ΔNIHSS at 24±2 hours after EVT
Time frame: 24±2 hours after EVT
the final infarct volume
Time frame: 72 hours post-randomization
early neurological deterioration (END)
Time frame: 1 day after reperfusion therapy
Postoperative pulmonary complications
Time frame: within 7 days after endovascular therapy
overall mRS distribution at 90 days
Time frame: 90 days after stroke onset
favorable functional outcome
Time frame: 90 days after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 39755573Hu 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.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruquan Han, Ph.D study director
Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normobaric high-concentration oxygen and Normobaric low-concentration oxygen in people with Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, Ph.D (+86 13701285393, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of early neurological improvement (ENI) (time frame: 24±2 hours after EVT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.