NCT05351073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

February 22, 2022

Last Update Submit

April 24, 2022

Conditions

Acute StrokeIschemic Stroke, Acute

Keywords

Acute strokeNormobaric oxygenStroke neuroprotection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Safety Outcome

    Day 1

  • Recruitment rate

    From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.

  • Final diagnosis

    From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.

  • Plateletto-lymphocyte ratio(PLR)

    Day1

  • Systemic immune-inflammation index (SII)

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

NBODRUG

Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)

Normobaric Oxygen Inhalation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
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

February 22, 2022

First Posted

April 28, 2022

Study Start

January 21, 2022

Primary Completion

July 20, 2022

Study Completion

October 20, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)