NCT00414726

Brief Summary

The purpose of this study is to compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom onset), to standard medical treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 16, 2010

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

December 21, 2006

Results QC Date

July 1, 2010

Last Update Submit

October 18, 2017

Conditions

Ischemic Stroke

Keywords

ischemic strokenormobaric oxygen therapy

Outcome Measures

Primary Outcomes (2)

  • Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.

    The NIHSS score ranges from 0 (best score) to 42 (worst score).

    24 hours

  • Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.

    The NIHSS score ranges from 0 (best score) to 42 (worst score).

    4 hours after starting treatment

Study Arms (2)

NBO (Normobaric Oxygen)

ACTIVE COMPARATOR

Oxygen, inhaled at 30-45L/min via a facemask for 8 hours

Drug: NBO (Normobaric Oxygen)Drug: Room Air

Room Air

PLACEBO COMPARATOR

Room Air, inhaled at 30-45L/min via a facemask for 8 hours

Drug: NBO (Normobaric Oxygen)Drug: Room Air

Interventions

NBO (Normobaric Oxygen)DRUG

High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.

NBO (Normobaric Oxygen)Room Air
Room AirDRUG

Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.

NBO (Normobaric Oxygen)Room Air

Eligibility Criteria

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

You may qualify if:

  • Age greater than or equal to 18 years.
  • Acute ischemic stroke in whom treatment can potentially be started within 9 hours after symptom onset. If the symptom onset time is unknown, the time of onset will be defined as the midpoint between the time when the subject was last seen neurologically intact, and when found to have a neurological deficit.
  • National Institutes of Health Stroke Scale (NIHSS) score 4 or greater.

You may not qualify if:

  • Patients being actively considered for intravenous or intra-arterial thrombolysis will be excluded.
  • Patients likely to have acute stroke intervention such as carotid endarterectomy or stent or angioplasty, hemicraniectomy, etc.
  • Rapidly improving neurological deficits (transient ischemic attack).
  • Known history of severe chronic obstructive pulmonary disease (Forced Expiratory Vital Capacity less than 1.0 or oxygen dependent).
  • More than 3 L/min oxygen required to maintain peripheral arterial oxygen saturation above 92%.
  • New York Heart Association Class III heart failure.
  • Endotracheal intubation prior to enrollment or impending need for artificial ventilation.
  • Coma (National Institutes of Health Stroke Scale item 1a score of 3).
  • Suspected seizure at or after onset of stroke, or a known active seizure disorder.
  • Blood glucose below 50 mg/dL or greater than 250 mg/dL prior to enrollment.
  • Concurrent severe non-stroke medical illness requiring admission to a non-neurological intensive care unit
  • Expected survival less than 90 days.
  • Any condition that might limit neurological assessment or follow-up in the opinion of the investigator.
  • Pre-menopausal women with a positive pregnancy blood test performed at admission.
  • Inability to obtain consent from the patient or legally authorized representative.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital, ACC-729C

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital, 75 Francis Street

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

  • Singhal AB, Benner T, Roccatagliata L, Koroshetz WJ, Schaefer PW, Lo EH, Buonanno FS, Gonzalez RG, Sorensen AG. A pilot study of normobaric oxygen therapy in acute ischemic stroke. Stroke. 2005 Apr;36(4):797-802. doi: 10.1161/01.STR.0000158914.66827.2e. Epub 2005 Mar 10.

    PMID: 15761201BACKGROUND

  • Kim HY, Singhal AB, Lo EH. Normobaric hyperoxia extends the reperfusion window in focal cerebral ischemia. Ann Neurol. 2005 Apr;57(4):571-5. doi: 10.1002/ana.20430.

    PMID: 15786465BACKGROUND

  • Singhal AB, Dijkhuizen RM, Rosen BR, Lo EH. Normobaric hyperoxia reduces MRI diffusion abnormalities and infarct size in experimental stroke. Neurology. 2002 Mar 26;58(6):945-52. doi: 10.1212/wnl.58.6.945.

    PMID: 11914413BACKGROUND

  • Singhal AB, Ratai E, Benner T, Vangel M, Lee V, Koroshetz WJ, Schaefer PW, Sorensen AG, Gonzalez RG. Magnetic resonance spectroscopy study of oxygen therapy in ischemic stroke. Stroke. 2007 Oct;38(10):2851-4. doi: 10.1161/STROKEAHA.107.487280. Epub 2007 Aug 30.

    PMID: 17761914BACKGROUND

  • Singhal AB. Oxygen therapy in stroke: past, present, and future. Int J Stroke. 2006 Nov;1(4):191-200. doi: 10.1111/j.1747-4949.2006.00058.x.

    PMID: 18706016BACKGROUND

  • Fujiwara N, Murata Y, Arai K, Egi Y, Lu J, Wu O, Singhal AB, Lo EH. Combination therapy with normobaric oxygen (NBO) plus thrombolysis in experimental ischemic stroke. BMC Neurosci. 2009 Jul 15;10:79. doi: 10.1186/1471-2202-10-79.

    PMID: 19604385BACKGROUND

  • Regenhardt RW, Gonzalez RG, He J, Lev MH, Singhal AB. Symmetric CTA Collaterals Identify Patients with Slow-progressing Stroke Likely to Benefit from Late Thrombectomy. Radiology. 2022 Feb;302(2):400-407. doi: 10.1148/radiol.2021210455. Epub 2021 Nov 2.

    PMID: 34726532DERIVED

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Aneesh B. Singhal, MD
Organization
Massachusetts General Hospital
asinghal@partners.org
617 726 8459

Study Officials

  • Aneesh B Singhal, MD

    Massachusetts General and Brigham & Women's Hospitals

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 20, 2017

Results First Posted

September 16, 2010

Record last verified: 2017-10

Locations

US(2)