100
90
80
70
*Plateau Stability: *This require stability of BOTH the calculated saturation and the reference oximeters. For regulatory purposes, plateaus must be stable for >60 seconds prior to sampling. Labview will define this and green light the calculated SO2 once stable. However, ideally the reference oximeters will also reach stability for 60 seconds (also will be noted as green light in labview). In subjects with low perfusion, reference oximeter stability may require 5-8 minutes of a stable calculated saturation values. Desaturation plateaus should not exceed 10 minutes total.
Hypoxia Lab Protocol 2024
94%
1
>60s*
>20s
Last updated Nov 25, 2024
9 / 1-2.5
(Lpm)
Air / N2
9 / 3-5
9 / 8-9
9 / 9**
6 / 8-9**
CO2 0.3-0.5lpm
throughout
6. Drop Air to 3LPM x 4s between plateaus
SaO2 (%)
16 17 18 19
= Run 1
= Run 2
96%
100%
2 3 4 5
84%
20 21 21 23 24
86%
6 7 8 9 10
25 26 27 28 29
72%
76%
11 12 13 14 15
** Actual flow rates required may vary significantly and should be adjusted based on flows required for higher SaO2 plateaus. Record flows for each run. If required flows vary significantly from those here, then check for leaks!
(optional)
(optional)
(optional)
(optional)
OLD VERSIONS BELOW
100
90
80
70
*Plateau Stability: *This require stability of BOTH the calculated saturation and the reference oximeters. For regulatory purposes, plateaus must be stable for >60 seconds prior to sampling. Labview will define this and green light the calculated SO2 once stable. However, ideally the reference oximeters will also reach stability for 60 seconds (also will be noted as green light in labview). In subjects with low perfusion, reference oximeter stability may require 5-8 minutes of a stable calculated saturation values. Desaturation plateaus should not exceed 10 minutes total.
Hypoxia Lab Protocol 6.2023
94%
1
>60s*
>20s
Last updated November 15, 2023
9 / 1-2.5
(Lpm)
Air / N2
9 / 3-5
9 / 8-9
9 / 9**
6 / 8-9**
CO2 0.3-0.5lpm
throughout
Drop Air to 3LPM x 4s between plateaus
SaO2 (%)
14 15 16 17
= Run 1
= Run 2
96%
100%
2 3 4 5
84%
18 19 20 21
86%
6 7 8 9
22 23 24 25
72%
76%
10 11 12 13
** Actual flow rates required may vary significantly and should be adjusted based on flows required for higher SaO2 plateaus. Record flows for each run. If required flows vary significantly from those here, then check for leaks!
100
90
80
70
1
>60s
>20s
SaO2 (%)
14 15 16 17
= Run 1
= Run 2
100%
2 3 4 5
18 19 20 21
6 7 8 9
22 23 24 25
10 11 12 13
100
90
80
70
*Plateau Stability: *This require stability of BOTH the calculated saturation and the reference oximeters. For regulatory purposes, plateaus must be stable for >60 seconds prior to sampling. Labview will define this and green light the calculated SO2 once stable. However, ideally the reference oximeters will also reach stability for 60 seconds (also will be noted as green light in labview). In subjects with low perfusion, reference oximeter stability may require 5-8 minutes of a stable calculated saturation values. Desaturation plateaus should not exceed 10 minutes total.
Hypoxia Lab Protocol 6.2023
92%
1
>60s*
>20s
Last updated June 15, 2023
9 / 1-2.5
(Lpm)
Air / N2
9 / 3-5
9 / 8-9
9 / 9**
6 / 8-9**
CO2 0.3-0.5lpm
throughout
Drop Air to 3LPM x 4s between plateaus
SaO2 (%)
14 15 16 17
= Run 1
= Run 2
100%
96%
2 3 4 5
82%
18 19 20 21
87%
6 7 8 9
22 23 24 25
73%
77%
10 11 12 13
** Actual flow rates required may vary significantly and should be adjusted based on flows required for higher SaO2 plateaus. Record flows for each run. If required flows vary significantly from those here, then check for leaks!
100
90
80
70
Example: Target samples per plateau = 5; Total number plateaus = 5; Total samples = 25; plateau and sample sizes above are an example, not intended to be a limit. Each plateau should be stable for >30s and time between samples should be >20s
Deasturation plateaus should not exceed 10 minutes. This protocol is provided as an example of targets. Actual plateaus may vary at PI discretion based on study subject physiology and safety.
*Time to stability of plateaus may vary, especially if low perfusion
** Actual flow rates required may vary significantly and should be adjusted based on flows required for higher SaO2 plateaus. Record flows for each run. If required flows vary significantly from those here, then check for leaks!
Open Ox Protocol
92%
1
>60s
>20s
Last updated May 5, 2023
9 / 1-2
(Lpm)
Air / N2
9 / 3-5
9 / 8-9
9 / 9**
6 / 8-9**
CO2 0.5
throughout
Allow calc sat to stabilize AND reference oximeters to stabilize before sampling
Drop Air to 3LPM x 4s between plateaus
SaO2 (%)
14 15 16 17
= Round 1
= Round 2
100%
96%
2 3 4 5
82%
18 19 20 21
87%
6 7 8 9
22 23 24 25
75%
75%
10 11 12 13
SaO2 (%)
100
90
80
70
99-97%
92-85%
84-78%
77-70%
Example: Target samples per plateau = 5; Total number plateaus = 5; Total samples = 25; plateau and sample sizes above are an example, not intended to be a limit. Each plateau should be stable for >30s and time between samples should be >20s
Deasturation plateaus should not exceed 10 minutes. This protocol is provided as an example of targets. Actual plateaus may vary at PI discretion based on study subject physiology and safety.
*Time to stability of plateaus may vary, especially if low perfusion
Example from ISO 80601-2-61:2017(E)
97-92%
2
3
4
5
1
7
14
15
16
6
9
17
18
19
8
11
20
21
22
10
13
23
24
25
12
>30s
>20s
Last updated November 15, 2022
100
90
80
70
100%
95%
Example: Target samples per plateau = 4; Total number plateaus = 4; Total samples = 26; plateau and sample sizes above are an example, not intended to be a limit. Each plateau should be stable for >30s and time between samples should be >20s.
Deasturation plateaus should not exceed 10 minutes. This protocol is provided as an example of targets. Actual plateaus may vary at PI discretion based on study subject physiology and safety.
*Time to stability of plateaus may vary, especially if low perfusion
Hypoxia Lab 2020 ISO 80601-2-61:2017(E)
85%
75%
100%
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
17
18
19
21
22
23
25
26
16
20
24
>30s*
>20s*
Last updated November 15, 2022
SaO2 (%)