Trial Outcomes & Findings for The Efficacy of Normobaric Oxygen on Chronic Cerebral Ischemia (NCT NCT03745092)
NCT ID: NCT03745092
Last Updated: 2020-04-08
Results Overview
The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central theta absolute power change rate was calculated as the theta (4-8Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The theta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the theta frequency band.
COMPLETED
NA
49 participants
30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG
2020-04-08
Participant Flow
Participant milestones
| Measure |
NBO Group
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
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 |
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
Total
n=49 Participants
Total of all reporting groups
|
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=23 Participants
|
38 Participants
n=49 Participants
|
17 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=23 Participants
|
11 Participants
n=49 Participants
|
9 Participants
n=26 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 8.4 • n=23 Participants
|
56.7 years
STANDARD_DEVIATION 11.8 • n=49 Participants
|
60.5 years
STANDARD_DEVIATION 8.3 • n=26 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=23 Participants
|
12 Participants
n=49 Participants
|
8 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=23 Participants
|
37 Participants
n=49 Participants
|
18 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
|
Region of Enrollment
China
|
23 participants
n=23 Participants
|
86 participants
n=49 Participants
|
26 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEGThe patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central theta absolute power change rate was calculated as the theta (4-8Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The theta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the theta frequency band.
Outcome measures
| Measure |
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
The Fronto-central Theta Absolute Power Change Rate
|
0.14 ratio
Interval -0.07 to 0.37
|
-0.12 ratio
Interval -0.24 to 0.04
|
PRIMARY outcome
Timeframe: 30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEGThe patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central delta absolute power change rate was calculated as the delta (1-4Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The delta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the delta frequency band.
Outcome measures
| Measure |
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
The Fronto-central Delta Absolute Power Reduction Rate
|
0.21 ratio
Interval 0.07 to 0.38
|
-0.01 ratio
Interval -0.2 to 0.15
|
SECONDARY outcome
Timeframe: 30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEGThe patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The post-intervention fronto-central theta/alpha ratio is computed as the theta absolute power/the alpha absolute power over the fronto-central electrodes (C3, C4, Cz, F3, F4, Fz) at the post-intervention EEG. The alpha and theta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the alpha (8-12Hz) and theta (4-8Hz) frequency band.
Outcome measures
| Measure |
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
The Post-intervention Fronto-central Theta/Alpha Ratio
|
0.36 ratio
Interval 0.16 to 0.49
|
0.35 ratio
Interval 0.21 to 0.79
|
SECONDARY outcome
Timeframe: 30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEGThe patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The post-intervention fronto-central (delta+theta)/(alpha+beta) ratio is computed as (the delta+theta absolute power)/(the alpha+beta absolute power) over the fronto-central electrodes (C3, C4, Cz, F3, F4, Fz) at the post-intervention EEG. The beta, alpha, theta and delta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the beta (12-20Hz), alpha (8-12Hz), theta (4-8Hz) and delta (1-4Hz) frequency band.
Outcome measures
| Measure |
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
The Post-intervention Fronto-central (Delta+Theta)/(Alpha+Beta) Ratio
|
0.64 ratio
Interval 0.34 to 0.92
|
0.58 ratio
Interval 0.42 to 1.29
|
SECONDARY outcome
Timeframe: 30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEGThe patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The post-intervention fronto-central delta/alpha ratio is computed as the delta absolute power/the alpha absolute power over the fronto-central electrodes (C3, C4, Cz, F3, F4, Fz) at the post-intervention EEG. The alpha and delta (1-4Hz) absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the alpha (8-12Hz) and delta (1-4Hz) frequency band.
Outcome measures
| Measure |
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
The Post-intervention Fronto-central Delta/Alpha Ratio
|
0.33 ratio
Interval 0.18 to 0.8
|
0.35 ratio
Interval 0.29 to 0.62
|
SECONDARY outcome
Timeframe: 30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEGThe entropy is computed via nonlinear dynamics method and represents the complexity of the signal in the information science initially (with units nat). It can also be applied in assessing the complexity of the EEG signal to evaluate the brain functions. The wavelet entropy analysis is a sub-type of entropy which is proceeded with wavelet transform. The wavelet entropy analysis provides a quantitative measure of the degree of disorder in the brain rhythm at various times in brain injury and recovery. The higher value of the wavelet entropy indicates the better brain functions. The fronto-central wavelet entropy change in this study is defined as the wavelet entropy value at the baseline EEG minus the post-intervention EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz).
Outcome measures
| Measure |
NBO Group
n=26 Participants
Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.
normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
|
Control Group
n=23 Participants
Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.
room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
|
|---|---|---|
|
The Fronto-central Wavelet Entropy Change
|
-0.15 nat
Standard Deviation 0.54
|
-0.01 nat
Standard Deviation 0.42
|
Adverse Events
NBO Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pro. Ran Meng
Xuanwu Hospital, Capital Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place