Trial Outcomes & Findings for Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline (NCT NCT05984186)
NCT ID: NCT05984186
Last Updated: 2024-10-08
Results Overview
The change in blood lactate starting from the exercise test throughout the recovery period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60).
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
All Participants
Subjects will receive High Velocity Therapy. There will be four different flow settings and FIO2 for a total of four groups. Each participants will complete all four arms in randomized order.
All 15 patients completed all 4 arms.
FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM
|
|---|---|
|
FiO2=100% With Flow=5LPM
STARTED
|
15
|
|
FiO2=100% With Flow=5LPM
COMPLETED
|
15
|
|
FiO2=100% With Flow=5LPM
NOT COMPLETED
|
0
|
|
FiO2=21% With Flow=25-35LPM
STARTED
|
15
|
|
FiO2=21% With Flow=25-35LPM
COMPLETED
|
15
|
|
FiO2=21% With Flow=25-35LPM
NOT COMPLETED
|
0
|
|
FiO2=100% With Flow=25-35LPM
STARTED
|
15
|
|
FiO2=100% With Flow=25-35LPM
COMPLETED
|
15
|
|
FiO2=100% With Flow=25-35LPM
NOT COMPLETED
|
0
|
|
FiO2=21% With Flow=5LPM
STARTED
|
15
|
|
FiO2=21% With Flow=5LPM
COMPLETED
|
15
|
|
FiO2=21% With Flow=5LPM
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
Subject will receive High Velocity Therapy; four different flow settings and FIO2 for a total of four groups.
FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-30LPM FiO2=100% with Flow=25-30LPM FiO2=21% with Flow=5LPM
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60).The change in blood lactate starting from the exercise test throughout the recovery period
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
Blood Lactate Change
TR
|
1.19 mmol/L
Standard Deviation .49
|
1.22 mmol/L
Standard Deviation .98
|
1.11 mmol/L
Standard Deviation .36
|
1.05 mmol/L
Standard Deviation .42
|
|
Blood Lactate Change
T2
|
9.85 mmol/L
Standard Deviation 2.24
|
9.63 mmol/L
Standard Deviation 2.32
|
9.55 mmol/L
Standard Deviation 1.48
|
9.56 mmol/L
Standard Deviation 2.19
|
|
Blood Lactate Change
T4
|
11.05 mmol/L
Standard Deviation 2.16
|
10.75 mmol/L
Standard Deviation 2.24
|
10.86 mmol/L
Standard Deviation 1.90
|
10.61 mmol/L
Standard Deviation 2.19
|
|
Blood Lactate Change
T6
|
11.60 mmol/L
Standard Deviation 1.96
|
11.33 mmol/L
Standard Deviation 2.03
|
10.83 mmol/L
Standard Deviation 1.81
|
10.89 mmol/L
Standard Deviation 2.05
|
|
Blood Lactate Change
T8
|
11.30 mmol/L
Standard Deviation 2.22
|
11.29 mmol/L
Standard Deviation 2.49
|
11.14 mmol/L
Standard Deviation 1.96
|
10.26 mmol/L
Standard Deviation 1.91
|
|
Blood Lactate Change
T10
|
11.30 mmol/L
Standard Deviation 2.33
|
11.13 mmol/L
Standard Deviation 2.41
|
10.63 mmol/L
Standard Deviation 2.03
|
10.22 mmol/L
Standard Deviation 1.92
|
|
Blood Lactate Change
T15
|
10.07 mmol/L
Standard Deviation 2.36
|
9.59 mmol/L
Standard Deviation 2.42
|
9.43 mmol/L
Standard Deviation 2.01
|
9.16 mmol/L
Standard Deviation 2.37
|
|
Blood Lactate Change
T20
|
8.73 mmol/L
Standard Deviation 2.24
|
8.20 mmol/L
Standard Deviation 2.26
|
8.04 mmol/L
Standard Deviation 2.06
|
7.73 mmol/L
Standard Deviation 2.02
|
|
Blood Lactate Change
T25
|
7.39 mmol/L
Standard Deviation 2.14
|
6.90 mmol/L
Standard Deviation 2.03
|
6.72 mmol/L
Standard Deviation 1.99
|
6.53 mmol/L
Standard Deviation 1.91
|
|
Blood Lactate Change
T30
|
6.22 mmol/L
Standard Deviation 1.66
|
5.84 mmol/L
Standard Deviation 1.91
|
5.49 mmol/L
Standard Deviation 1.52
|
5.47 mmol/L
Standard Deviation 1.63
|
|
Blood Lactate Change
T40
|
4.49 mmol/L
Standard Deviation 1.29
|
4.31 mmol/L
Standard Deviation 1.59
|
4.07 mmol/L
Standard Deviation 1.23
|
3.99 mmol/L
Standard Deviation 1.21
|
|
Blood Lactate Change
T50
|
3.39 mmol/L
Standard Deviation .95
|
3.27 mmol/L
Standard Deviation 1.10
|
2.95 mmol/L
Standard Deviation .91
|
2.96 mmol/L
Standard Deviation .94
|
|
Blood Lactate Change
T60
|
2.26 mmol/L
Standard Deviation .73
|
2.61 mmol/L
Standard Deviation .90
|
2.37 mmol/L
Standard Deviation .72
|
2.41 mmol/L
Standard Deviation .73
|
SECONDARY outcome
Timeframe: Prior to the Wingate test (TR) and after at 1min (T1), 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.Population: Subjects that had the data collected for the specified time point.
The change in respiratory rate starting from the exercise test throughout the recovery period
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
Respiratory Rate Change
T1
|
29.01 Breaths per min
Standard Deviation 5.19
|
25.05 Breaths per min
Standard Deviation 7.34
|
25.41 Breaths per min
Standard Deviation 8.02
|
27.3 Breaths per min
Standard Deviation 5.53
|
|
Respiratory Rate Change
T2
|
25.63 Breaths per min
Standard Deviation 6.81
|
25.97 Breaths per min
Standard Deviation 5.45
|
25.59 Breaths per min
Standard Deviation 6.02
|
22.73 Breaths per min
Standard Deviation 6.52
|
|
Respiratory Rate Change
TR
|
14.04 Breaths per min
Standard Deviation 4.71
|
14.35 Breaths per min
Standard Deviation 3.91
|
15.24 Breaths per min
Standard Deviation 5.93
|
13.59 Breaths per min
Standard Deviation 3.79
|
|
Respiratory Rate Change
T4
|
25.53 Breaths per min
Standard Deviation 5.95
|
22.47 Breaths per min
Standard Deviation 6.85
|
22.63 Breaths per min
Standard Deviation 6.67
|
21.39 Breaths per min
Standard Deviation 6.29
|
|
Respiratory Rate Change
T6
|
22.98 Breaths per min
Standard Deviation 5.81
|
20.18 Breaths per min
Standard Deviation 5.97
|
20.04 Breaths per min
Standard Deviation 7.25
|
19.09 Breaths per min
Standard Deviation 5.83
|
|
Respiratory Rate Change
T8
|
20.33 Breaths per min
Standard Deviation 6.84
|
18.04 Breaths per min
Standard Deviation 4.78
|
19.02 Breaths per min
Standard Deviation 8.39
|
17.84 Breaths per min
Standard Deviation 6.80
|
|
Respiratory Rate Change
T10
|
21.20 Breaths per min
Standard Deviation 4.19
|
18.91 Breaths per min
Standard Deviation 4.20
|
18.35 Breaths per min
Standard Deviation 6.45
|
17.51 Breaths per min
Standard Deviation 5.72
|
|
Respiratory Rate Change
T15
|
19.12 Breaths per min
Standard Deviation 5.17
|
16.19 Breaths per min
Standard Deviation 3.91
|
17.91 Breaths per min
Standard Deviation 5.31
|
15.17 Breaths per min
Standard Deviation 7.04
|
|
Respiratory Rate Change
T20
|
17.89 Breaths per min
Standard Deviation 5.56
|
14.05 Breaths per min
Standard Deviation 3.61
|
16.51 Breaths per min
Standard Deviation 6.58
|
14.32 Breaths per min
Standard Deviation 5.54
|
|
Respiratory Rate Change
T25
|
16.20 Breaths per min
Standard Deviation 5.90
|
12.64 Breaths per min
Standard Deviation 4.40
|
16.61 Breaths per min
Standard Deviation 5.07
|
13.07 Breaths per min
Standard Deviation 4.90
|
|
Respiratory Rate Change
T30
|
16.01 Breaths per min
Standard Deviation 4.66
|
12.00 Breaths per min
Standard Deviation 5.05
|
12.91 Breaths per min
Standard Deviation 4.45
|
12.68 Breaths per min
Standard Deviation 4.56
|
|
Respiratory Rate Change
T40
|
15.09 Breaths per min
Standard Deviation 4.82
|
11.59 Breaths per min
Standard Deviation 3.01
|
12.92 Breaths per min
Standard Deviation 4.31
|
12.46 Breaths per min
Standard Deviation 4.68
|
|
Respiratory Rate Change
T50
|
14.03 Breaths per min
Standard Deviation 4.19
|
11.43 Breaths per min
Standard Deviation 3.83
|
13.14 Breaths per min
Standard Deviation 6.73
|
10.81 Breaths per min
Standard Deviation 3.94
|
|
Respiratory Rate Change
T60
|
14.03 Breaths per min
Standard Deviation 3.24
|
10.77 Breaths per min
Standard Deviation 3.64
|
12.99 Breaths per min
Standard Deviation 4.85
|
10.83 Breaths per min
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Prior to the Wingate test (TR) and after 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.Population: Subjects that had this data collected for the specified time point.
The change in heart rate starting from the exercise test throughout the recovery period
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
Heart Rate Change
T10
|
100.73 Beats per min
Standard Deviation 8.83
|
102.73 Beats per min
Standard Deviation 10.50
|
101.80 Beats per min
Standard Deviation 10.18
|
99.87 Beats per min
Standard Deviation 8.36
|
|
Heart Rate Change
T15
|
98.73 Beats per min
Standard Deviation 8.96
|
101.00 Beats per min
Standard Deviation 7.65
|
97.86 Beats per min
Standard Deviation 7.85
|
97.20 Beats per min
Standard Deviation 10.48
|
|
Heart Rate Change
T25
|
96.87 Beats per min
Standard Deviation 11.11
|
96.27 Beats per min
Standard Deviation 10.93
|
93.20 Beats per min
Standard Deviation 9.26
|
93.33 Beats per min
Standard Deviation 10.44
|
|
Heart Rate Change
T30
|
93.40 Beats per min
Standard Deviation 10.18
|
95.93 Beats per min
Standard Deviation 9.91
|
94.80 Beats per min
Standard Deviation 9.21
|
94.07 Beats per min
Standard Deviation 9.48
|
|
Heart Rate Change
T40
|
93.87 Beats per min
Standard Deviation 11.18
|
90.53 Beats per min
Standard Deviation 8.72
|
92.47 Beats per min
Standard Deviation 8.43
|
89.47 Beats per min
Standard Deviation 9.58
|
|
Heart Rate Change
T50
|
90.73 Beats per min
Standard Deviation 8.25
|
90.53 Beats per min
Standard Deviation 9.35
|
89.00 Beats per min
Standard Deviation 9.89
|
90.00 Beats per min
Standard Deviation 12.26
|
|
Heart Rate Change
T60
|
89.47 Beats per min
Standard Deviation 8.90
|
89.87 Beats per min
Standard Deviation 10.79
|
85.57 Beats per min
Standard Deviation 9.00
|
86.13 Beats per min
Standard Deviation 9.31
|
|
Heart Rate Change
TR
|
78.7 Beats per min
Standard Deviation 11.87
|
77.43 Beats per min
Standard Deviation 10.93
|
77.33 Beats per min
Standard Deviation 11.08
|
81.13 Beats per min
Standard Deviation 14.94
|
|
Heart Rate Change
T2
|
121.60 Beats per min
Standard Deviation 10.03
|
120.53 Beats per min
Standard Deviation 17.22
|
117.13 Beats per min
Standard Deviation 7.64
|
116.93 Beats per min
Standard Deviation 12.14
|
|
Heart Rate Change
T4
|
107.27 Beats per min
Standard Deviation 10.98
|
107.93 Beats per min
Standard Deviation 11.97
|
103.27 Beats per min
Standard Deviation 10.40
|
105.00 Beats per min
Standard Deviation 10.45
|
|
Heart Rate Change
T6
|
103.33 Beats per min
Standard Deviation 8.59
|
106.27 Beats per min
Standard Deviation 11.65
|
100.80 Beats per min
Standard Deviation 10.36
|
101.20 Beats per min
Standard Deviation 9.95
|
|
Heart Rate Change
T8
|
102.93 Beats per min
Standard Deviation 8.53
|
104.67 Beats per min
Standard Deviation 10.76
|
101.73 Beats per min
Standard Deviation 8.55
|
101.20 Beats per min
Standard Deviation 9.12
|
|
Heart Rate Change
T20
|
97.13 Beats per min
Standard Deviation 9.49
|
98.47 Beats per min
Standard Deviation 8.40
|
95.80 Beats per min
Standard Deviation 9.37
|
95.13 Beats per min
Standard Deviation 10.23
|
SECONDARY outcome
Timeframe: Prior to the Wingate test (TR) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.Population: Subjects that had the data collected at that specified time point.
The change in SpO2 starting from the exercise test throughout the recovery period.
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
SpO2 Change
TR
|
99.07 Percent oxygen
Standard Deviation .80
|
98.71 Percent oxygen
Standard Deviation 1.14
|
98.13 Percent oxygen
Standard Deviation 1.60
|
98.49 Percent oxygen
Standard Deviation .99
|
|
SpO2 Change
T2
|
98.20 Percent oxygen
Standard Deviation .94
|
98.13 Percent oxygen
Standard Deviation 1.13
|
98.47 Percent oxygen
Standard Deviation 1.46
|
99.33 Percent oxygen
Standard Deviation .72
|
|
SpO2 Change
T4
|
97.73 Percent oxygen
Standard Deviation 1.10
|
97.53 Percent oxygen
Standard Deviation 1.13
|
98.53 Percent oxygen
Standard Deviation .83
|
99.00 Percent oxygen
Standard Deviation .85
|
|
SpO2 Change
T6
|
97.73 Percent oxygen
Standard Deviation .96
|
96.80 Percent oxygen
Standard Deviation 1.52
|
98.27 Percent oxygen
Standard Deviation 1.10
|
99.00 Percent oxygen
Standard Deviation .85
|
|
SpO2 Change
T15
|
96.87 Percent oxygen
Standard Deviation .99
|
96.33 Percent oxygen
Standard Deviation .90
|
98.13 Percent oxygen
Standard Deviation .74
|
98.27 Percent oxygen
Standard Deviation 1.33
|
|
SpO2 Change
T20
|
96.53 Percent oxygen
Standard Deviation 1.06
|
96.43 Percent oxygen
Standard Deviation .94
|
98.13 Percent oxygen
Standard Deviation .74
|
98.47 Percent oxygen
Standard Deviation .74
|
|
SpO2 Change
T25
|
96.47 Percent oxygen
Standard Deviation 1.19
|
95.87 Percent oxygen
Standard Deviation 1.55
|
98.00 Percent oxygen
Standard Deviation .76
|
98.00 Percent oxygen
Standard Deviation 1.41
|
|
SpO2 Change
T50
|
96.00 Percent oxygen
Standard Deviation 1.20
|
96.27 Percent oxygen
Standard Deviation 1.33
|
98.13 Percent oxygen
Standard Deviation .64
|
98.00 Percent oxygen
Standard Deviation 1.89
|
|
SpO2 Change
T60
|
96.00 Percent oxygen
Standard Deviation 1.41
|
95.87 Percent oxygen
Standard Deviation 1.41
|
97.71 Percent oxygen
Standard Deviation .73
|
98.07 Percent oxygen
Standard Deviation 2.37
|
|
SpO2 Change
T8
|
97.00 Percent oxygen
Standard Deviation 1.31
|
96.87 Percent oxygen
Standard Deviation .99
|
98.33 Percent oxygen
Standard Deviation .90
|
98.87 Percent oxygen
Standard Deviation .64
|
|
SpO2 Change
T10
|
97.20 Percent oxygen
Standard Deviation 1.08
|
96.60 Percent oxygen
Standard Deviation .83
|
98.27 Percent oxygen
Standard Deviation .88
|
98.47 Percent oxygen
Standard Deviation 1.46
|
|
SpO2 Change
T30
|
95.80 Percent oxygen
Standard Deviation 1.15
|
96.00 Percent oxygen
Standard Deviation 1.20
|
97.73 Percent oxygen
Standard Deviation .96
|
98.27 Percent oxygen
Standard Deviation .96
|
|
SpO2 Change
T40
|
96.00 Percent oxygen
Standard Deviation 1.89
|
95.73 Percent oxygen
Standard Deviation 1.22
|
98.87 Percent oxygen
Standard Deviation .64
|
97.60 Percent oxygen
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.Population: Subjects that had this data collected for the specified time point.
The change in systolic blood pressure starting from the exercise test throughout the recovery period.
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
Systolic Blood Pressure Change
TR
|
125.73 mmHG
Standard Deviation 16.88
|
126.27 mmHG
Standard Deviation 8.49
|
125.20 mmHG
Standard Deviation 12.40
|
121.33 mmHG
Standard Deviation 10.47
|
|
Systolic Blood Pressure Change
T15
|
124.31 mmHG
Standard Deviation 15.48
|
120.93 mmHG
Standard Deviation 13.79
|
124.86 mmHG
Standard Deviation 13.20
|
124.46 mmHG
Standard Deviation 12.76
|
|
Systolic Blood Pressure Change
T20
|
117.93 mmHG
Standard Deviation 17.26
|
118.93 mmHG
Standard Deviation 13.65
|
120.80 mmHG
Standard Deviation 15.79
|
120.79 mmHG
Standard Deviation 15.49
|
|
Systolic Blood Pressure Change
T5
|
132.87 mmHG
Standard Deviation 17.11
|
138.57 mmHG
Standard Deviation 20.49
|
136.53 mmHG
Standard Deviation 16.25
|
133.93 mmHG
Standard Deviation 13.60
|
|
Systolic Blood Pressure Change
T10
|
124.14 mmHG
Standard Deviation 15.03
|
123.47 mmHG
Standard Deviation 13.94
|
126.47 mmHG
Standard Deviation 12.72
|
125.20 mmHG
Standard Deviation 15.84
|
|
Systolic Blood Pressure Change
T25
|
116.60 mmHG
Standard Deviation 14.27
|
117.86 mmHG
Standard Deviation 10.74
|
114.20 mmHG
Standard Deviation 10.69
|
115.07 mmHG
Standard Deviation 13.37
|
|
Systolic Blood Pressure Change
T30
|
115.40 mmHG
Standard Deviation 12.07
|
116.67 mmHG
Standard Deviation 10.19
|
116.87 mmHG
Standard Deviation 13.33
|
114.07 mmHG
Standard Deviation 14.03
|
|
Systolic Blood Pressure Change
T40
|
114.33 mmHG
Standard Deviation 14.94
|
114.93 mmHG
Standard Deviation 11.16
|
116.60 mmHG
Standard Deviation 12.89
|
113.93 mmHG
Standard Deviation 8.34
|
|
Systolic Blood Pressure Change
T50
|
117.47 mmHG
Standard Deviation 21.23
|
114.47 mmHG
Standard Deviation 9.77
|
115.87 mmHG
Standard Deviation 10.49
|
1113.93 mmHG
Standard Deviation 11.32
|
|
Systolic Blood Pressure Change
T60
|
114.07 mmHG
Standard Deviation 12.46
|
114.47 mmHG
Standard Deviation 11.12
|
114.86 mmHG
Standard Deviation 9.43
|
113.67 mmHG
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.Population: Subjects that had this data collected for the specified time point.
The change in diastolic blood pressure change starting from the exercise test throughout the recovery period.
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
Diastolic Blood Pressure Change
T15
|
71.31 mmHg
Standard Deviation 14.33
|
70.80 mmHg
Standard Deviation 12.19
|
74.29 mmHg
Standard Deviation 5.46
|
69.92 mmHg
Standard Deviation 6.63
|
|
Diastolic Blood Pressure Change
T20
|
70.47 mmHg
Standard Deviation 6.06
|
72.57 mmHg
Standard Deviation 7.24
|
77.67 mmHg
Standard Deviation 20.70
|
77.07 mmHg
Standard Deviation 18.85
|
|
Diastolic Blood Pressure Change
T30
|
70.13 mmHg
Standard Deviation 7.18
|
72.07 mmHg
Standard Deviation 7.08
|
69.93 mmHg
Standard Deviation 4.68
|
70.87 mmHg
Standard Deviation 8.84
|
|
Diastolic Blood Pressure Change
TR
|
75.73 mmHg
Standard Deviation 8.50
|
76.73 mmHg
Standard Deviation 7.86
|
75.53 mmHg
Standard Deviation 8.56
|
75.00 mmHg
Standard Deviation 9.46
|
|
Diastolic Blood Pressure Change
T5
|
67.20 mmHg
Standard Deviation 8.60
|
69.14 mmHg
Standard Deviation 8.96
|
68.93 mmHg
Standard Deviation 5.64
|
68.53 mmHg
Standard Deviation 6.72
|
|
Diastolic Blood Pressure Change
T10
|
70.00 mmHg
Standard Deviation 10.99
|
70.20 mmHg
Standard Deviation 6.67
|
69.40 mmHg
Standard Deviation 4.55
|
72.20 mmHg
Standard Deviation 16.40
|
|
Diastolic Blood Pressure Change
T25
|
70.27 mmHg
Standard Deviation 6.60
|
74.86 mmHg
Standard Deviation 9.45
|
70.53 mmHg
Standard Deviation 6.14
|
74.07 mmHg
Standard Deviation 11.15
|
|
Diastolic Blood Pressure Change
T40
|
69.27 mmHg
Standard Deviation 9.09
|
76.60 mmHg
Standard Deviation 12.48
|
72.80 mmHg
Standard Deviation 11.45
|
76.13 mmHg
Standard Deviation 12.86
|
|
Diastolic Blood Pressure Change
T50
|
72.27 mmHg
Standard Deviation 20.09
|
71.27 mmHg
Standard Deviation 7.64
|
71.07 mmHg
Standard Deviation 6.61
|
71.73 mmHg
Standard Deviation 7.27
|
|
Diastolic Blood Pressure Change
T60
|
69.71 mmHg
Standard Deviation 7.72
|
71.40 mmHg
Standard Deviation 9.16
|
71.50 mmHg
Standard Deviation 5.23
|
71.33 mmHg
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: Immediately after the Wingate test (T0) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.The change in the subjects perceived level of exertion starting from after the exercise test throughout the recovery period. The scale will be 0-10; a lower score is a lower level of exhaustion, a higher score is a higher level of exhaustion.
Outcome measures
| Measure |
FiO2=21% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=21% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=5LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
FiO2=100% With Flow=25-35LPM
n=15 Participants
High Velocity Therapy: Four different flow settings and FiO2
|
|---|---|---|---|---|
|
Perceived Level of Exertion Change
T0
|
8.40 units on a scale (0-10)
Standard Deviation 2.10
|
7.86 units on a scale (0-10)
Standard Deviation 2.80
|
8.54 units on a scale (0-10)
Standard Deviation 1.98
|
8.93 units on a scale (0-10)
Standard Deviation 1.33
|
|
Perceived Level of Exertion Change
T4
|
5.73 units on a scale (0-10)
Standard Deviation 2.25
|
5.87 units on a scale (0-10)
Standard Deviation 2.50
|
5.67 units on a scale (0-10)
Standard Deviation 2.13
|
5.80 units on a scale (0-10)
Standard Deviation 1.47
|
|
Perceived Level of Exertion Change
T60
|
.73 units on a scale (0-10)
Standard Deviation .80
|
.60 units on a scale (0-10)
Standard Deviation .74
|
.71 units on a scale (0-10)
Standard Deviation .73
|
.93 units on a scale (0-10)
Standard Deviation .96
|
|
Perceived Level of Exertion Change
T2
|
7.07 units on a scale (0-10)
Standard Deviation 1.87
|
6.87 units on a scale (0-10)
Standard Deviation 2.47
|
6.93 units on a scale (0-10)
Standard Deviation 2.02
|
6.93 units on a scale (0-10)
Standard Deviation 1.75
|
|
Perceived Level of Exertion Change
T6
|
4.80 units on a scale (0-10)
Standard Deviation 2.34
|
4.93 units on a scale (0-10)
Standard Deviation 2.71
|
5.00 units on a scale (0-10)
Standard Deviation 2.20
|
4.60 units on a scale (0-10)
Standard Deviation 1.68
|
|
Perceived Level of Exertion Change
T8
|
4.13 units on a scale (0-10)
Standard Deviation 2.07
|
4.13 units on a scale (0-10)
Standard Deviation 2.75
|
3.87 units on a scale (0-10)
Standard Deviation 2.45
|
3.67 units on a scale (0-10)
Standard Deviation 2.29
|
|
Perceived Level of Exertion Change
T10
|
3.67 units on a scale (0-10)
Standard Deviation 2.32
|
3.67 units on a scale (0-10)
Standard Deviation 2.53
|
3.47 units on a scale (0-10)
Standard Deviation 2.61
|
3.07 units on a scale (0-10)
Standard Deviation 2.19
|
|
Perceived Level of Exertion Change
T15
|
2.80 units on a scale (0-10)
Standard Deviation 2.18
|
2.67 units on a scale (0-10)
Standard Deviation 2.19
|
2.60 units on a scale (0-10)
Standard Deviation 2.13
|
2.47 units on a scale (0-10)
Standard Deviation 2.07
|
|
Perceived Level of Exertion Change
T20
|
2.33 units on a scale (0-10)
Standard Deviation 2.06
|
2.27 units on a scale (0-10)
Standard Deviation 2.12
|
2.20 units on a scale (0-10)
Standard Deviation 1.90
|
2.07 units on a scale (0-10)
Standard Deviation 1.79
|
|
Perceived Level of Exertion Change
T25
|
2.07 units on a scale (0-10)
Standard Deviation 1.94
|
1.93 units on a scale (0-10)
Standard Deviation 1.87
|
1.80 units on a scale (0-10)
Standard Deviation 1.78
|
1.67 units on a scale (0-10)
Standard Deviation 1.54
|
|
Perceived Level of Exertion Change
T30
|
1.73 units on a scale (0-10)
Standard Deviation 1.62
|
1.47 units on a scale (0-10)
Standard Deviation 1.64
|
1.67 units on a scale (0-10)
Standard Deviation 1.68
|
1.43 units on a scale (0-10)
Standard Deviation 1.55
|
|
Perceived Level of Exertion Change
T40
|
1.40 units on a scale (0-10)
Standard Deviation 1.35
|
1.27 units on a scale (0-10)
Standard Deviation 1.49
|
1.13 units on a scale (0-10)
Standard Deviation 1.36
|
1.13 units on a scale (0-10)
Standard Deviation 1.19
|
|
Perceived Level of Exertion Change
T50
|
.93 units on a scale (0-10)
Standard Deviation .96
|
.93 units on a scale (0-10)
Standard Deviation 1.03
|
.93 units on a scale (0-10)
Standard Deviation 1.03
|
1.07 units on a scale (0-10)
Standard Deviation 1.22
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place