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

Stroke, Acute Clinical Trial

— NBOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05039697
• Other study ID #: OPENS-2L
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2023
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: 01083199439
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

Other:
• oxygen
deliver high flow oxygen (10L/min)

Locations

Country	Name	City	State
China	Baojun Hou	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale	the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)	1 year ± 30 days after randomization
Secondary	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.	1 year ± 30 days after randomization
Secondary	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	1 year ± 30 days after randomization
Secondary	Functional independence	The Proportion of mRS 0-1	1 year ± 30 days after randomization
Secondary	The Proportion of mRS 0-3	secondary clinical efficacy endpoint	1 year ± 30 days after randomization
Secondary	Barthel Index (BI)	he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);	1 year ± 30 days after randomization
Secondary	All-cause mortality	clinical safety endpoint;	1 year ± 30 days after randomization
Secondary	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.	1 year ± 30 days after randomization
Secondary	kaplan-meier curve	clinical efficacy endpoint	1 year ± 30 days after randomization