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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Stroke; Ischemic Stroke, Acute
• Intervention / Treatment: Drug: NBO

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital，Capital Medical University
      • Contact: Xunming Ji, MD; Phone Number: 010-83198952; Email: jixm@ccmu.edu.cn
      • Contact: Milan Jia, MM; Phone Number: 8618323209109; Email: jiaml@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normobaric Oxygen Inhalation Group; 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; Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.	Day 1
Recruitment rate	The rate of patients successfully recruited to the trial by prehospital paramedics.	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.	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.	Day1
Systemic immune-inflammation index (SII)	Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.	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.	Day 1

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Anticipated): July 20, 2022
• Study Completion (Anticipated): October 20, 2022

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Acute stroke; Normobaric oxygen; Stroke neuroprotection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NO-SUSPENSION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No