Trial Outcomes & Findings for Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation (NCT NCT05083351)
NCT ID: NCT05083351
Last Updated: 2024-09-19
Results Overview
The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
1-5 hours
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
MightySat
All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).
MightySat: Noninvasive pulse oximeter
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
MightySat
All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).
MightySat: Noninvasive pulse oximeter
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Did not meet data inclusion criteria
|
8
|
|
Overall Study
Did not meet eligibility criteria
|
19
|
|
Overall Study
Study Staff Decision
|
19
|
Baseline Characteristics
Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation
Baseline characteristics by cohort
| Measure |
MightySat
n=39 Participants
All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).
MightySat: Noninvasive pulse oximeter
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-5 hoursThe SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.
Outcome measures
| Measure |
MightySat
n=39 Participants
All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).
MightySat: Noninvasive pulse oximeter
|
|---|---|
|
SpO2 Accuracy of the MightySat Pulse Oximeter
|
1.30 % of oxygen saturated hemoglobin
|
Adverse Events
MightySat
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MightySat
n=39 participants at risk
All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).
MightySat: Noninvasive pulse oximeter
|
|---|---|
|
Nervous system disorders
Anxiety
|
2.6%
1/39 • 1 to 5 hours
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
7.7%
3/39 • 1 to 5 hours
|
|
Surgical and medical procedures
Arterial line (healing)
|
7.7%
3/39 • 1 to 5 hours
|
|
Cardiac disorders
Hypotension
|
5.1%
2/39 • 1 to 5 hours
|
|
Cardiac disorders
Abnormal ECG
|
5.1%
2/39 • 1 to 5 hours
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • 1 to 5 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place