Acute StrokePhase 2NO SUSPENSIONNCT05351073
The Prehospital Administration of Normobaric Oxygen in Suspected Stroke
A Phase 2 study testing NBO in people with Acute Stroke and Ischemic Stroke, Acute, run by Capital Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Acute
- What is being tested?
- NBO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2022to 20 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 or more.
- Suspected stroke screened by the "Gaze- Face Arm Speech Time" scale (G-FAST score ≥ 1).
- Within 24 hours of symptom onset
- SpO2 > 94%.
Who cannot join
- Coma: Glasgow coma score (GCS) < 8.
- Hypoglycemia: Blood glucose < 2.8mmol /L.
- Known history of seizure.
- Recent stroke or brain trauma within past 30 days.
- Previous Modified Rankin Scale (mRS) ≥2.
- Rapid improvement of neurological dysfunction (deficit present less than 15 min).
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- Unstable vital signs.
- Known respiratory distress, respiratory dysfunction, or any contraindications to high-flow oxygen inhalation therapy.
- Patient unable to cooperate with the trial procedure.
- Any condition which might increase the risk to the patient in the judgment of the investigator.
- Patient or available legally authorized representative unable to provide written or witnessed oral consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100053
Xunming Ji, MD, 010-83198952, jixm@ccmu.edu.cn
Milan Jia, MM, 8618323209109, jiaml@ccmu.edu.cn
About this study
Official title: The Safety and Feasibility of Normobaric Oxygen Administration for SUSPEcted Acute Stroke uNder Pre-hoSpItal cONdition--A Pilot Trial
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.
Read the detailed description
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.
- Conditions
- Acute Stroke, Ischemic Stroke, Acute
- Being tested
- NBO
- Keywords
- Acute stroke, Normobaric oxygen, Stroke neuroprotection
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBODrug
Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)
| Study group | Role | What they receive |
|---|---|---|
| Normobaric Oxygen Inhalation Group | Experimental | 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. Receives: Drug: NBO |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
Safety Outcome
Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.
Measured: Day 1
Recruitment rate
The rate of patients successfully recruited to the trial by prehospital paramedics.
Measured: 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.
Measured: 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.
Measured: Day1
Systemic immune-inflammation index (SII)
Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start21 Jan 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351073
- Sponsor's protocol ID
- NO-SUSPENSION
- Acronym
- NO SUSPENSION
- Status last verified
- Apr 2022
- First submitted
- 22 Feb 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Normobaric Oxygen Administration for SUSPEcted Acute Stroke uNder Pre-hoSpItal cONdition--A Pilot Trial
- ClinicalTrials.gov ID
- NCT05351073
- Acronym / sponsor ID
- NO SUSPENSION / NO-SUSPENSION
- Conditions
- Acute Stroke, Ischemic Stroke, Acute
- Keywords
- Acute stroke, Normobaric oxygen, Stroke neuroprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 28 Apr 2022 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normobaric Oxygen Inhalation Group | Experimental | Drug: NBOParticipants 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. |
| Control Group | No intervention | –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. |
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 or more.
- Suspected stroke screened by the "Gaze- Face Arm Speech Time" scale (G-FAST score ≥ 1).
- Within 24 hours of symptom onset
- SpO2 > 94%.
Key exclusion criteria (11 listed)
- Coma: Glasgow coma score (GCS) < 8.
- Hypoglycemia: Blood glucose < 2.8mmol /L.
- Known history of seizure.
- Recent stroke or brain trauma within past 30 days.
- Previous Modified Rankin Scale (mRS) ≥2.
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 |
|---|---|---|
| NBOOxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa) | Drug | Normobaric Oxygen Inhalation Group |
Primary outcome
Time intervals of the prehospital transportation process
Time frame: Day 1
Time intervals between stroke onset, paramedic arrival on the scene, the departure from the scene, and admission to the hospital emergency department.
6 secondary outcomes
Safety Outcome
Time frame: Day 1
Recruitment rate
Time frame: From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.
Final diagnosis
Time frame: From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.
Plateletto-lymphocyte ratio(PLR)
Time frame: Day1
Systemic immune-inflammation index (SII)
Time frame: Day 1
Neutrophil-to-lymphocyte ratio (NLR)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBO in people with Acute Stroke and Ischemic Stroke, Acute, run by Capital Medical University 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 11 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time intervals of the prehospital transportation process (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2022.