search
Back to results

Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset:Longterm Outcome (NBOL)

Primary Purpose

Stroke, Acute, Hypoxia-Ischemia, Brain, ENDOVASCULAR TREATMENT

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
oxygen
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old.
  • The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion;
  • NIHSS score ≥ 10 points;
  • (Level of consciousness) NIHSS score 0 or 1;
  • The time from onset to randomization is within 6 hours of onset;
  • The mRS score before stroke is 0-1;
  • The patient has good compliance and can complete the operation with local anesthesia;
  • The patient can cooperate with this study and follow-up in the future
  • Patient and family members sign informed consent。-

Exclusion Criteria:

  • Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
  • Seizures at stroke onset;
  • Intracranial hemorrhage;
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
  • Platelet count of less than 100,000 per cubic millimeter;
  • Severe hepatic or renal dysfunction;
  • Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
  • >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
  • Medically unstable;
  • Life expectancy<90 days;
  • Evidence of intracranial tumor;

Sites / Locations

  • Baojun HouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomy

Control group Inhale air placebo plus endovascular mechanical thrombectomy

Arm Description

Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30minutes after admission) at a ventilation rate of 10L/min using a sealed non-ventilating oxygen storagemask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.

For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%

Outcomes

Primary Outcome Measures

Modified Rankin Scale
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)

Secondary Outcome Measures

EuroQol- 5 Dimension (EQ-5D)
EuroQol five dimensions questionnaire (EQ-5D)EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The proportion of good prognosis
the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2
Functional independence
The Proportion of mRS 0-1
The Proportion of mRS 0-3
secondary clinical efficacy endpoint
Barthel Index (BI)
he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
All-cause mortality
clinical safety endpoint;
New major vascular events
clinical safety endpoint; Major vascular events include fatal or nonfatal cardiac events, fatal or nonfatal stroke, or fatal or nonfatal major peripheral arterial or thrombo-embolic events.
kaplan-meier curve
clinical efficacy endpoint

Full Information

First Posted
April 6, 2021
Last Updated
August 28, 2023
Sponsor
Capital Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05039697
Brief Title
Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset:Longterm Outcome
Acronym
NBOL
Official Title
Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset:Longterm Outcome Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall incidence of good outcome for AIS following endovascular treatment is only proximately 50%. Whether NBO was safe and effective to improve acute ischemic stroke prognosis is still unclear. The investigators' hypothesis is thatNBO is a safe and effective strategy to improve longterm outcome in AIS patients undergoing endovascular treatment.
Detailed Description
NBO therapy is to deliver high flow oxygen (10L/min) through an oxygen storage mask. This treatment should be started in the emergency room immediately after the patient is randomized into the group, and oxygen should be continued for 4 hours. In previous clinical studies of NBO, patients who have not receive revascularization often choose NBO for 8 hours, and studies have concluded that oxygen inhalation for more than 10 hours may bring about the risk of oxygen poisoning. However, a too short treatment time may not bring benefits. Secondly, ideally, we want to ensure that stroke patients receive NBO treatment before achieving reperfusion to protect the ischemic brain tissue, and add 1-2 hours after reperfusion. In the clinical environment after the patient arrives in the emergency department, it takes 2-3 hours to complete the revascularization process. Therefore, we believe that 4 hours of oxygen inhalation is reasonable. And our single-center study also supports that NBO treatment for 4 hours is beneficial. The specific content is as follows: In the emergency room, patients who are assessed for suspected large blood vessels of acute anterior circulation will be randomized after signing the informed consent. If the subject is randomly divided into NBO+ET group, by putting the patient on Oxygen mask, and then immediately give oxygen (10L/min). NBO treatment is no later than half an hour after randomization. Oxygen comes from the hospital's oxygen center and is transported through wall pipes (oxygen concentration: 100%). The oxygen mask and the wall oxygen are connected by a 1.5 meter long oxygen pipe. When the patient is transferred to the operating room, we provide oxygen through a portable oxygen cylinder (capacity: 4L). In addition, in the operating room and intensive care unit, patients continue to be given wall oxygen therapy until the oxygen inhalation lasts for 4 hours. The arterial blood gas was drawn after 4 hours of oxygen inhalation. The control group directly inhales room air through the patient's nasal cavity without using any equipment. At the same time, patients in the control group were also drawn blood gas analysis at corresponding time points (approximately 4 hours after randomization).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Hypoxia-Ischemia, Brain, ENDOVASCULAR TREATMENT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomy
Arm Type
Experimental
Arm Description
Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30minutes after admission) at a ventilation rate of 10L/min using a sealed non-ventilating oxygen storagemask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
Arm Title
Control group Inhale air placebo plus endovascular mechanical thrombectomy
Arm Type
Placebo Comparator
Arm Description
For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%
Intervention Type
Other
Intervention Name(s)
oxygen
Intervention Description
deliver high flow oxygen (10L/min)
Primary Outcome Measure Information:
Title
Modified Rankin Scale
Description
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)
Time Frame
1 year ± 30 days after randomization
Secondary Outcome Measure Information:
Title
EuroQol- 5 Dimension (EQ-5D)
Description
EuroQol five dimensions questionnaire (EQ-5D)EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
1 year ± 30 days after randomization
Title
The proportion of good prognosis
Description
the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2
Time Frame
1 year ± 30 days after randomization
Title
Functional independence
Description
The Proportion of mRS 0-1
Time Frame
1 year ± 30 days after randomization
Title
The Proportion of mRS 0-3
Description
secondary clinical efficacy endpoint
Time Frame
1 year ± 30 days after randomization
Title
Barthel Index (BI)
Description
he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
Time Frame
1 year ± 30 days after randomization
Title
All-cause mortality
Description
clinical safety endpoint;
Time Frame
1 year ± 30 days after randomization
Title
New major vascular events
Description
clinical safety endpoint; Major vascular events include fatal or nonfatal cardiac events, fatal or nonfatal stroke, or fatal or nonfatal major peripheral arterial or thrombo-embolic events.
Time Frame
1 year ± 30 days after randomization
Title
kaplan-meier curve
Description
clinical efficacy endpoint
Time Frame
1 year ± 30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old. The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; NIHSS score ≥ 10 points; (Level of consciousness) NIHSS score 0 or 1; The time from onset to randomization is within 6 hours of onset; The mRS score before stroke is 0-1; The patient has good compliance and can complete the operation with local anesthesia; The patient can cooperate with this study and follow-up in the future Patient and family members sign informed consent。- Exclusion Criteria: Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization; Seizures at stroke onset; Intracranial hemorrhage; Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; Platelet count of less than 100,000 per cubic millimeter; Severe hepatic or renal dysfunction; Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines; Medically unstable; Life expectancy<90 days; Evidence of intracranial tumor;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD
Phone
01083199439
Email
jixm@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Wei, PhD
Phone
02259065309
Email
drweiming@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD
Organizational Affiliation
Xuan Wu Hospital#Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Baojun Hou
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baojun HOU, M.D
Phone
8683198129
Email
bestjunren2008@126.com
First Name & Middle Initial & Last Name & Degree
Wenbo Zhao, M.D
Phone
+86 15810766407
Email
zhaowb.cool@163.com
First Name & Middle Initial & Last Name & Degree
Xunming Ji, M.D,Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset:Longterm Outcome

We'll reach out to this number within 24 hrs