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Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial

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ClinicalTrials.gov Identifier: NCT00414726
Recruitment Status : Terminated (Imbalance in deaths favoring control arm; deaths not attributed to treatment by the blinded external medical monitor.)
First Posted : December 22, 2006
Results First Posted : September 16, 2010
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ischemic Stroke
Interventions Drug: NBO (Normobaric Oxygen)
Drug: Room Air
Enrollment 85
Recruitment Details February 2007-June 2009
Pre-assignment Details  
Arm/Group Title Normobaric Oxygen Room Air
Hide Arm/Group Description Oxygen, inhaled at 30-45L/min via a facemask for 8 hours Room Air, inhaled at 30-45L/min via a facemask for 8 hours
Period Title: Overall Study
Started 43 42
Completed 43 41
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Normobaric Oxygen Room Air Total
Hide Arm/Group Description Oxygen, inhaled at 30-45L/min via a facemask for 8 hours Room Air, inhaled at 30-45L/min via a facemask for 8 hours Total of all reporting groups
Overall Number of Baseline Participants 43 42 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 85 participants
74.1  (14) 73.4  (14) 73.7  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Female
27
  62.8%
17
  40.5%
44
  51.8%
Male
16
  37.2%
25
  59.5%
41
  48.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Hispanic or Latino
0
   0.0%
6
  14.3%
6
   7.1%
Not Hispanic or Latino
42
  97.7%
36
  85.7%
78
  91.8%
Unknown or Not Reported
1
   2.3%
0
   0.0%
1
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.3%
2
   4.8%
3
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.7%
1
   2.4%
3
   3.5%
White
40
  93.0%
39
  92.9%
79
  92.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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.
Hide Description The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normobaric Oxygen Room Air
Hide Arm/Group Description:
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
Overall Number of Participants Analyzed 43 42
Mean (95% Confidence Interval)
Unit of Measure: 0-24 hour change in NIHSS score
0.17
(-1.07 to 1.41)
-0.73
(-2.31 to 0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normobaric Oxygen, Room Air
Comments Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(>20).
2.Primary Outcome
Title 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.
Hide Description The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame 4 hours after starting treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normobaric Oxygen Room Air
Hide Arm/Group Description:
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
Overall Number of Participants Analyzed 43 42
Mean (95% Confidence Interval)
Unit of Measure: 0-4 hour change in NIHSS score
-0.37
(-1.20 to 0.46)
-0.43
(-1.43 to 0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normobaric Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.
Time Frame AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Adverse Event Reporting Description Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
 
Arm/Group Title Normobaric Oxygen Room Air
Hide Arm/Group Description Oxygen, inhaled at 30-45L/min via a facemask for 8 hours Room Air, inhaled at 30-45L/min via a facemask for 8 hours
All-Cause Mortality
Normobaric Oxygen Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Normobaric Oxygen Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   24/43 (55.81%)   20/41 (48.78%) 
Cardiac disorders     
Cardiac Arrhythmia  1/43 (2.33%)  3/41 (7.32%) 
Cardiac General  3/43 (6.98%)  2/41 (4.88%) 
General disorders     
Constitutional Symptoms  0/43 (0.00%)  1/41 (2.44%) 
Death  17/43 (39.53%)  7/41 (17.07%) 
Hemorrhage/Bleeding  4/43 (9.30%)  0/41 (0.00%) 
Pain  1/43 (2.33%)  0/41 (0.00%) 
Hepatobiliary disorders     
Hepatobiliary/Pancreas  1/43 (2.33%)  0/41 (0.00%) 
Infections and infestations     
Infection  2/43 (4.65%)  1/41 (2.44%) 
Investigations     
Metabolic/Laboratory  0/43 (0.00%)  1/41 (2.44%) 
Nervous system disorders     
Neurology  8/43 (18.60%)  3/41 (7.32%) 
Renal and urinary disorders     
Renal/Genitourinary  0/43 (0.00%)  2/41 (4.88%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary/Upper Respiratory  3/43 (6.98%)  2/41 (4.88%) 
Vascular disorders     
Vascular  0/43 (0.00%)  2/41 (4.88%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normobaric Oxygen Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   42/43 (97.67%)   41/41 (100.00%) 
Blood and lymphatic system disorders     
Blood/Bone Marrow  5/43 (11.63%)  3/41 (7.32%) 
Lymphatics  9/43 (20.93%)  7/41 (17.07%) 
Cardiac disorders     
Cardiac Arrhythmia  9/43 (20.93%)  7/41 (17.07%) 
Cardiac General  12/43 (27.91%)  6/41 (14.63%) 
Gastrointestinal disorders     
Gastrointestinal  14/43 (32.56%)  18/41 (43.90%) 
General disorders     
Constitutional Symptoms  16/43 (37.21%)  10/41 (24.39%) 
Hemorrhage/Bleeding  14/43 (32.56%)  15/41 (36.59%) 
Pain  18/43 (41.86%)  15/41 (36.59%) 
Infections and infestations     
Infection  16/43 (37.21%)  13/41 (31.71%) 
Investigations     
Metabolic/Laboratory  4/43 (9.30%)  3/41 (7.32%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal/Soft Tissue  0/43 (0.00%)  3/41 (7.32%) 
Nervous system disorders     
Neurology  27/43 (62.79%)  18/41 (43.90%) 
Renal and urinary disorders     
Renal/Genitourinary  10/43 (23.26%)  11/41 (26.83%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary/Upper Respiratory  23/43 (53.49%)  13/41 (31.71%) 
Skin and subcutaneous tissue disorders     
Dermatology/Skin  14/43 (32.56%)  11/41 (26.83%) 
Early termination leading to small numbers of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aneesh B. Singhal, MD
Organization: Massachusetts General Hospital
Phone: 617 726 8459
Responsible Party: Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00414726     History of Changes
Other Study ID Numbers: R01NS051412 ( U.S. NIH Grant/Contract )
P50NS051343 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2006
First Posted: December 22, 2006
Results First Submitted: July 1, 2010
Results First Posted: September 16, 2010
Last Update Posted: October 20, 2017