A Phase 2 interventional study of NBO in Acute Stroke and Ischemic Stroke, Acute, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Capital Medical University · Phase 2, Interventional, and Treatment
The primary purpose of this study is to explore the feasibility and safety of normobaric oxygen therapy (NBO) under pre-hospital condition in patients with suspected stroke.
Despite the application of thrombolytic drugs and endovascular treatment, there is still a gap between the successful recanalization and ideal clinical outcomes for stroke patients. Neuroprotective treatment is considered as a promising adjuvant to ameliorate this situation. Previous researches demonstrated the neuroprotective effects of Normobaric Hyperoxia (NBO) in animal models from multiple perspectives. Moreover, NBO is distinctive for its ubiquity, conveniency, high compatibility, and wide adaptability, making it superior to other neuroprotective interventions in a pre-hospital setting. Therefore, the investigators conducted this pilot study to further explore the feasibility and safety of NBO under a pre-hospital condition in patients with suspected stroke.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the intervention group will receive oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa) after randomization until adimisson to the hospital. Participants will subsequently receive standard diagnosis and treatment service according to the guidelines during hospitalization.
Drug: NBO
Participants in the control group will not receive oxygen inhalation therapy during ambulance transportation. Participants will subsequently receive standard diagnosis and treatment service according to the guidelines during hospitalization.
Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)
Time intervals of the prehospital transportation process
Time intervals between stroke onset, paramedic arrival on the scene, the departure from the scene, and admission to the hospital emergency department.
Time frame: Day 1
Safety Outcome
Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.
Time frame: Day 1
Recruitment rate
The rate of patients successfully recruited to the trial by prehospital paramedics.
Time frame: From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.
Final diagnosis
The final diagnosis of the patients enrolled in the trial.
Time frame: From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.
Plateletto-lymphocyte ratio(PLR)
The platelet-to-lymphocyte ratio (PLR) is calculated as the absolute count of platelet divided by the absolute count of lymphocytes.
Time frame: Day1
Systemic immune-inflammation index (SII)
Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.
Time frame: Day 1
Neutrophil-to-lymphocyte ratio (NLR)
Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes.
Time frame: Day 1
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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