Trial Outcomes & Findings for Alternate Methodology of Pulse Oximeter Validation (NCT NCT03628560)
NCT ID: NCT03628560
Last Updated: 2026-08-11
Results Overview
The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
TERMINATED
NA
2 participants
1 study day
2026-08-11
Participant Flow
Participant milestones
| Measure |
Desaturation
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
Run #1: RespirAct Step [Normocapnia]
STARTED
|
2
|
|
Run #1: RespirAct Step [Normocapnia]
COMPLETED
|
2
|
|
Run #1: RespirAct Step [Normocapnia]
NOT COMPLETED
|
0
|
|
Run #2: RespirAct Slope [Normocapnia]
STARTED
|
2
|
|
Run #2: RespirAct Slope [Normocapnia]
COMPLETED
|
2
|
|
Run #2: RespirAct Slope [Normocapnia]
NOT COMPLETED
|
0
|
|
Run #3: RespirAct Step [Hypocapnia]
STARTED
|
2
|
|
Run #3: RespirAct Step [Hypocapnia]
COMPLETED
|
2
|
|
Run #3: RespirAct Step [Hypocapnia]
NOT COMPLETED
|
0
|
|
Run #4: RespirAct Slope [Hypocapnia]
STARTED
|
2
|
|
Run #4: RespirAct Slope [Hypocapnia]
COMPLETED
|
2
|
|
Run #4: RespirAct Slope [Hypocapnia]
NOT COMPLETED
|
0
|
|
Run #5: ROBD Step
STARTED
|
2
|
|
Run #5: ROBD Step
COMPLETED
|
2
|
|
Run #5: ROBD Step
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alternate Methodology of Pulse Oximeter Validation
Baseline characteristics by cohort
| Measure |
Desaturation
n=2 Participants
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 1 study dayPopulation: This analysis only applies to Runs #1-4 as the ROBD device is distinct from the RespirAct and cannot provide the measured parameter.
The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
Outcome measures
| Measure |
Desaturation
n=2 Participants
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With RespirAct-derived End-tidal PAO2 Values
Run #4: RespirAct Slope Hypocapnia desaturation sequence
|
6.7 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With RespirAct-derived End-tidal PAO2 Values
Run #1: RespirAct Step-Wise Normocapnia desaturation sequence
|
3.1 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With RespirAct-derived End-tidal PAO2 Values
Run #2: RespirAct Slope Normocapnia desaturation sequence
|
5.3 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With RespirAct-derived End-tidal PAO2 Values
Run #3: RespirAct Step-Wise Hypocapnia desaturation sequence
|
5.4 percentage
|
PRIMARY outcome
Timeframe: 1 study dayThe unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
Outcome measures
| Measure |
Desaturation
n=2 Participants
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values
Run #1: RespirAct Step-Wise Normocapnia desaturation sequence
|
2.9 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values
Run #2: RespirAct Slope Normocapnia desaturation sequence
|
2.2 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values
Run #3: RespirAct Step-Wise Hypocapnia desaturation sequence
|
2.2 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values
Run #4: RespirAct Slope Hypocapnia desaturation sequence
|
1.3 percentage
|
|
Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values
Run #5: ROBD Step-Wise desaturation sequence
|
2.2 percentage
|
PRIMARY outcome
Timeframe: 1 study dayPopulation: This analysis only applies to Runs #1-4 as the ROBD device is distinct from the RespirAct and cannot provide the measured parameter.
A\[RMS\] of RespirAct-derived end-tidal PAO2 values with co-oximeter measured arterial PaO2 values. The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
Outcome measures
| Measure |
Desaturation
n=2 Participants
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
PAO2 Values
Run #1: RespirAct Step-Wise Normocapnia desaturation sequence
|
6.5 percentage
|
|
PAO2 Values
Run #2: RespirAct Slope Normocapnia desaturation sequence
|
14.2 percentage
|
|
PAO2 Values
Run #3: RespirAct Step-Wise Hypocapnia desaturation sequence
|
1.8 percentage
|
|
PAO2 Values
Run #4: RespirAct Slope Hypocapnia desaturation sequence
|
3.4 percentage
|
SECONDARY outcome
Timeframe: 1 study dayPopulation: This analysis only applies to Runs #1-4 as the ROBD device is distinct from the RespirAct and cannot provide the measured parameter. It is necessary to determine which of the four runs were STEP and which were SLOPE for this outcome. Runs #1 \& 3 were the two in which STEP-WISE desaturation was performed; similarly, Runs #2 \& 4 were SLOPE. Note that the amalgamation of the data from the two Runs is based upon STEP/SLOPE and is independent of carbon dioxide value (i.e. Hypocapnia \& Normocapnia).
The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
Outcome measures
| Measure |
Desaturation
n=2 Participants
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
Accuracy, A[RMS], When a Step-wise Desaturation Sequence is Used Against a Slope Desaturation Sequence.
Step-wise Desaturation (Runs #1 and #3)
|
2.4 percentage
|
|
Accuracy, A[RMS], When a Step-wise Desaturation Sequence is Used Against a Slope Desaturation Sequence.
Slope Desaturation (Runs #2 and #4)
|
2.2 percentage
|
SECONDARY outcome
Timeframe: 1 study dayPopulation: This analysis only applies to Runs #1-4 as the ROBD device is distinct from the RespirAct and cannot provide the measured parameter. It is necessary to determine which of the four runs were NORMOCAPNIA and which were HYPOCAPNIA for this outcome. Runs #1 \& 2 were the two in which NORMOCAPNIA condition was performed; similarly, Runs #3 \& 4 were HYPOCAPNIA. Runs #1 \& 2 are amalgamated to represent the condition of NORMOCAPNIA and Runs #3 \& 4 represent HYPOCAPNIA.
A\[RMS\] when hypocapnia desaturation is compared to normocapnia desaturation. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
Outcome measures
| Measure |
Desaturation
n=2 Participants
The study will consist of five controlled desaturation runs with SaO2 reduced from 100 to 70% followed by a return to 100%:
Run #1: RespirAct step \[normocapnia\] Run #2: RespirAct slope \[normocapnia\] Run #3: RespirAct step \[hypocapnia\] Run #4: RespirAct slope \[hypocapnia\] Run #5: ROBD step
|
|---|---|
|
Level of PaCO2 (Hypocapnia Versus Normocapnia)
Hypocapnia Desaturation (Runs #1 and #2)
|
2.5 percentage
|
|
Level of PaCO2 (Hypocapnia Versus Normocapnia)
Normocapnia Desaturation (Runs #3 and #4)
|
1.7 percentage
|
Adverse Events
Desaturation
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