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The Prehospital Administration of Normobaric Oxygen in Suspected Stroke (NO SUSPENSION)

Primary Purpose

Acute Stroke, Ischemic Stroke, Acute

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NBO
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Acute stroke, Normobaric oxygen, Stroke neuroprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years or more.
  2. Suspected stroke screened by the "Gaze- Face Arm Speech Time" scale (G-FAST score ≥ 1).
  3. Within 24 hours of symptom onset
  4. SpO2 > 94%.

Exclusion Criteria:

  1. Coma: Glasgow coma score (GCS) < 8.
  2. Hypoglycemia: Blood glucose < 2.8mmol /L.
  3. Known history of seizure.
  4. Recent stroke or brain trauma within past 30 days.
  5. Previous Modified Rankin Scale (mRS) ≥2.
  6. Rapid improvement of neurological dysfunction (deficit present less than 15 min).
  7. Unstable vital signs.
  8. Known respiratory distress, respiratory dysfunction, or any contraindications to high-flow oxygen inhalation therapy.
  9. Patient unable to cooperate with the trial procedure.
  10. Any condition which might increase the risk to the patient in the judgment of the investigator.
  11. Patient or available legally authorized representative unable to provide written or witnessed oral consent.

Sites / Locations

  • Xuanwu Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Normobaric Oxygen Inhalation Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety Outcome
Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.
Recruitment rate
The rate of patients successfully recruited to the trial by prehospital paramedics.
Final diagnosis
The final diagnosis of the patients enrolled in the trial.
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.
Systemic immune-inflammation index (SII)
Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.
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.

Full Information

First Posted
February 22, 2022
Last Updated
April 24, 2022
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05351073
Brief Title
The Prehospital Administration of Normobaric Oxygen in Suspected Stroke
Acronym
NO SUSPENSION
Official Title
The Safety and Feasibility of Normobaric Oxygen Administration for SUSPEcted Acute Stroke uNder Pre-hoSpItal cONdition--A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Anticipated)
Study Completion Date
October 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke, Ischemic Stroke, Acute
Keywords
Acute stroke, Normobaric oxygen, Stroke neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normobaric Oxygen Inhalation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NBO
Intervention Description
Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)
Primary Outcome Measure Information:
Title
Time intervals of the prehospital transportation process
Description
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
Secondary Outcome Measure Information:
Title
Safety Outcome
Description
Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.
Time Frame
Day 1
Title
Recruitment rate
Description
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.
Title
Final diagnosis
Description
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.
Title
Plateletto-lymphocyte ratio(PLR)
Description
The platelet-to-lymphocyte ratio (PLR) is calculated as the absolute count of platelet divided by the absolute count of lymphocytes.
Time Frame
Day1
Title
Systemic immune-inflammation index (SII)
Description
Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.
Time Frame
Day 1
Title
Neutrophil-to-lymphocyte ratio (NLR)
Description
Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%. Exclusion Criteria: 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). 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.
Facility Information:
Facility Name
Xuanwu Hospital，Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD
Phone
010-83198952
Email
jixm@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Milan Jia, MM
Phone
8618323209109
Email
jiaml@ccmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

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