Trial Outcomes & Findings for Normobaric Hyperoxia for Intracerebral Hemorrhage (NCT NCT04144868)
NCT ID: NCT04144868
Last Updated: 2025-04-30
Results Overview
modified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
90 days
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
NBO Group
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.23 years
STANDARD_DEVIATION 10 • n=48 Participants
|
63.71 years
STANDARD_DEVIATION 9.58 • n=48 Participants
|
62.97 years
STANDARD_DEVIATION 9.77 • n=96 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=48 Participants
|
14 Participants
n=48 Participants
|
31 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=48 Participants
|
34 Participants
n=48 Participants
|
65 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
48 participants
n=48 Participants
|
48 participants
n=48 Participants
|
96 participants
n=96 Participants
|
|
Onset-to-needle time
|
5.85 hours
STANDARD_DEVIATION 4.5 • n=48 Participants
|
7.91 hours
STANDARD_DEVIATION 6.18 • n=48 Participants
|
6.89 hours
STANDARD_DEVIATION 5.48 • n=96 Participants
|
|
Hypertension
|
36 participants
n=48 Participants
|
29 participants
n=48 Participants
|
65 participants
n=96 Participants
|
|
Hyperlipidemia
|
7 participants
n=48 Participants
|
9 participants
n=48 Participants
|
16 participants
n=96 Participants
|
|
Diabetes
|
13 participants
n=48 Participants
|
8 participants
n=48 Participants
|
21 participants
n=96 Participants
|
|
Stroke
|
12 participants
n=48 Participants
|
7 participants
n=48 Participants
|
19 participants
n=96 Participants
|
|
Smoking
|
12 participants
n=48 Participants
|
7 participants
n=48 Participants
|
19 participants
n=96 Participants
|
|
Drinking
|
15 participants
n=48 Participants
|
15 participants
n=48 Participants
|
30 participants
n=96 Participants
|
|
Systolic blood pressure at admission
|
159.15 mmHg
STANDARD_DEVIATION 24.58 • n=48 Participants
|
158.65 mmHg
STANDARD_DEVIATION 27.99 • n=48 Participants
|
158.90 mmHg
STANDARD_DEVIATION 26.20 • n=96 Participants
|
|
Diastolic blood pressure at admission
|
92.65 mmHg
STANDARD_DEVIATION 16.05 • n=48 Participants
|
89.98 mmHg
STANDARD_DEVIATION 14.64 • n=48 Participants
|
91.31 mmHg
STANDARD_DEVIATION 15.34 • n=96 Participants
|
|
GCS score
|
14 scores
n=48 Participants
|
13 scores
n=48 Participants
|
14 scores
n=96 Participants
|
|
NIHSS score
|
10 scores
n=48 Participants
|
13 scores
n=48 Participants
|
12 scores
n=96 Participants
|
|
Hematoma volume
|
16.77 mL
STANDARD_DEVIATION 7.18 • n=48 Participants
|
17.59 mL
STANDARD_DEVIATION 6.98 • n=48 Participants
|
17.18 mL
STANDARD_DEVIATION 7.06 • n=96 Participants
|
|
Absolute perihematoma edema volume
|
24.19 mL
STANDARD_DEVIATION 9.42 • n=48 Participants
|
25.55 mL
STANDARD_DEVIATION 10.38 • n=48 Participants
|
24.87 mL
STANDARD_DEVIATION 9.88 • n=96 Participants
|
|
Relative perihematoma edema volume
|
1.53 ratio
STANDARD_DEVIATION 0.49 • n=48 Participants
|
1.48 ratio
STANDARD_DEVIATION 0.28 • n=48 Participants
|
1.50 ratio
STANDARD_DEVIATION 0.40 • n=96 Participants
|
PRIMARY outcome
Timeframe: 90 daysmodified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Percentage of Patients With mRS 0-3
|
39 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 3 daysThe NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
NIHSS Scores
|
9 score on scale
Interval 7.0 to 12.0
|
12 score on scale
Interval 7.0 to 16.0
|
SECONDARY outcome
Timeframe: 7 daysThe NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
NIHSS Scores
|
7 score on scale
Interval 5.0 to 11.0
|
10 score on scale
Interval 5.25 to 13.0
|
SECONDARY outcome
Timeframe: 14 daysThe NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
NIHSS Scores
|
5 score on scale
Interval 3.0 to 7.0
|
7 score on scale
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: 3 daysGlasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Glasgow Coma Scale
|
15 score on scale
Interval 13.0 to 15.0
|
14 score on scale
Interval 11.0 to 15.0
|
SECONDARY outcome
Timeframe: 7 daysGlasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Glasgow Coma Scale
|
15 score on scale
Interval 14.0 to 15.0
|
15 score on scale
Interval 13.0 to 15.0
|
SECONDARY outcome
Timeframe: 14 daysGlasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Glasgow Coma Scale
|
15 score on scale
Interval 15.0 to 15.0
|
15 score on scale
Interval 14.0 to 15.0
|
SECONDARY outcome
Timeframe: 90 daysBarthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Barthel Index
|
80 score on scale
Interval 55.0 to 88.75
|
47.5 score on scale
Interval 35.0 to 83.75
|
SECONDARY outcome
Timeframe: 90 daysmodified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
Outcome measures
| Measure |
NBO Group
n=48 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
mRS Distribution
|
2 score on scale
Interval 1.0 to 3.0
|
3 score on scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 3 daysPopulation: There were 2 patients missing imaging data in each group at 3 days.
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Outcome measures
| Measure |
NBO Group
n=46 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=46 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Hematoma Volume
|
14.89 mL
Standard Deviation 6.05
|
16.8 mL
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: 7 daysPopulation: There were 3 patients in the NBO group and 4 patients in the control group missing imaging data at 7 days.
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Outcome measures
| Measure |
NBO Group
n=45 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=44 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Hematoma Volume
|
11.14 mL
Standard Deviation 4.93
|
13.26 mL
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: 14 daysPopulation: There were 4 patients in the NBO group and 2 patients in the control group missing imaging data at 14 days.
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Outcome measures
| Measure |
NBO Group
n=44 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=46 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Hematoma Volume
|
5.85 mL
Standard Deviation 4.02
|
6.37 mL
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: 3 daysPopulation: There were 2 patients missing imaging data in each group at 3 days.
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Outcome measures
| Measure |
NBO Group
n=46 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=46 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Absolute Perihematomal Edema Volume
|
30.51 mL
Standard Deviation 10.35
|
33.51 mL
Standard Deviation 11.67
|
SECONDARY outcome
Timeframe: 7 daysPopulation: There were 3 patients in the NBO group and 4 patients in the control group missing imaging data at 7 days.
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Outcome measures
| Measure |
NBO Group
n=45 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=44 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Absolute Perihematomal Edema Volume
|
28.43 mL
Standard Deviation 15.59
|
37.53 mL
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: 14 daysPopulation: There were 4 patients in the NBO group and 2 patients in the control group missing imaging data at 14 days.
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Outcome measures
| Measure |
NBO Group
n=44 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=46 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Absolute Perihematomal Edema Volume
|
16.17 mL
Standard Deviation 8.36
|
20.93 mL
Standard Deviation 12.71
|
SECONDARY outcome
Timeframe: 3 daysPopulation: There were 2 patients missing imaging data in each group at 3 days.
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
Outcome measures
| Measure |
NBO Group
n=46 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=46 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Relative Perihematomal Edema Volume
|
1.99 ratio
Standard Deviation 0.58
|
1.94 ratio
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 7 daysPopulation: There were 3 patients in the NBO group and 4 patients in the control group missing imaging data at 7 days.
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
Outcome measures
| Measure |
NBO Group
n=45 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=44 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Relative Perihematomal Edema Volume
|
1.69 ratio
Standard Deviation 0.69
|
2.18 ratio
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 14 daysPopulation: There were 4 patients in the NBO group and 2 patients in the control group missing imaging data at 14 days.
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
Outcome measures
| Measure |
NBO Group
n=44 Participants
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=46 Participants
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Relative Perihematomal Edema Volume
|
0.96 ratio
Standard Deviation 0.43
|
1.23 ratio
Standard Deviation 0.71
|
Adverse Events
NBO Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NBO Group
n=48 participants at risk
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
|
Control Group
n=48 participants at risk
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infections
|
18.8%
9/48 • Number of events 9 • From randomization to 90 days.
Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
|
25.0%
12/48 • Number of events 12 • From randomization to 90 days.
Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
|
|
Blood and lymphatic system disorders
Acid-base imbalances
|
4.2%
2/48 • Number of events 2 • From randomization to 90 days.
Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
|
2.1%
1/48 • Number of events 1 • From randomization to 90 days.
Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
|
|
Vascular disorders
Hematoma Expansion
|
8.3%
4/48 • Number of events 4 • From randomization to 90 days.
Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
|
6.2%
3/48 • Number of events 3 • From randomization to 90 days.
Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
|
Additional Information
Zhiying Chen
Affiliated Hospital of Jiujiang University
Phone: +86 13767263459
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place