Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

NCT05404373 | Completed DMC

• 1 other identifier: TD-NBO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.

Conditions

Stroke, Acute; Neuroprotection; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• Cerebral infarct volume

  The infarct volume is evaluated by MRI or CT scan

  Within 72 hours after randomization

Secondary Outcomes (18)

• Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

  24hours, 72hours, day7 after randomization

• The proportion of good prognosis

  90 ± 10 days after randomization

• neurological function improvement rate

  Time Frame: 24 ± 6 hours

• modified Rankin Scale score (mRS) score

  30 ± 7 days, 90 ± 10 days after randomization;

• Vascular recanalization rate

  Time Frame: 4 hours ± 15 minutes

Study Arms (4)

Low flow oxygen group

PLACEBO COMPARATOR

patients were randomized into the Low flow oxygen group and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

Other: Low flow oxygen

NBO group (2h)

EXPERIMENTAL

patients were randomized into the NBO group (2h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 2 hours.

Other: Normobaric Hyperoxia (NBO)

NBO group (4h)

EXPERIMENTAL

patients were randomized into the NBO group (4h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

Other: Normobaric Hyperoxia (NBO)

NBO group (6h)

EXPERIMENTAL

patients were randomized into the NBO group (6h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 6 hours.

Other: Normobaric Hyperoxia (NBO)

Interventions

Normobaric Hyperoxia (NBO) OTHER

NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups

NBO group (2h); NBO group (4h); NBO group (6h)

Low flow oxygen OTHER

immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

Low flow oxygen group

Eligibility Criteria

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

You may qualify if:

• Symptoms and signs were consistent with acute anterior circulation stroke,
• NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
• Met the indications for endovascular therapy;
• (Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
• The time from onset to randomization was within 24 hours;
• Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
• Patients and their families signed informed consent

You may not qualify if:

• Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
• Seizures at stroke onset;
• Intracranial hemorrhage;
• Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR \> 3.0 or PTT \> 3 times normal;
• Platelet count of less than 100,000 per cubic millimeter;
• Severe hepatic or renal dysfunction;
• Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg)
• Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol) Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
• \>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
• Medically unstable;
• Life expectancy\<90 days;
• Patients who could not complete the 90-day follow-up;
• Evidence of intracranial tumor;
• Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;

Sponsors & Collaborators

• Capital Medical University: lead
• Tianjin Huanhu Hospital: collaborator

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (1)

• Li W, Wang S, Liu L, Chen J, Lan J, Ding J, Chen Z, Yuan S, Qi Z, Wei M, Ji X. Normobaric Hyperoxia Combined With Endovascular Treatment Based on Temporal Gradient: A Dose-Escalation Study. Stroke. 2024 Jun;55(6):1468-1476. doi: 10.1161/STROKEAHA.123.046106. Epub 2024 May 15.

  PMID: 38747162 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: June 20, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-06

Locations

CN (1)