Trial Outcomes & Findings for Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx (NCT NCT05690633)
NCT ID: NCT05690633
Last Updated: 2026-05-13
Results Overview
Difference between the average oropharyngeal oxygen saturation and the average extremity oxygen saturation which were recorded every 2 minutes for a total of 30 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Palate
The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
Tongue
The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx
Baseline characteristics by cohort
| Measure |
Palate
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
Tongue
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Height
|
150 centimeters
n=1512 Participants
|
161.5 centimeters
n=504 Participants
|
155 centimeters
n=2016 Participants
|
|
Weight
|
41 kilograms
n=1512 Participants
|
52 kilograms
n=504 Participants
|
50 kilograms
n=2016 Participants
|
|
BMI
|
20 kg/m2
n=1512 Participants
|
21 kg/m2
n=504 Participants
|
20 kg/m2
n=2016 Participants
|
|
ASA physical status
I
|
5 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
10 Participants
n=2016 Participants
|
|
ASA physical status
II
|
14 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
41 Participants
n=2016 Participants
|
|
ASA physical status
III
|
25 Participants
n=1512 Participants
|
12 Participants
n=504 Participants
|
37 Participants
n=2016 Participants
|
|
Age, Categorical
<=18 years
|
50 Participants
n=1512 Participants
|
50 Participants
n=504 Participants
|
100 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Continuous
|
12 years
n=1512 Participants
|
14 years
n=504 Participants
|
13 years
n=2016 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
57 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=1512 Participants
|
23 Participants
n=504 Participants
|
43 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=1512 Participants
|
50 Participants
n=504 Participants
|
99 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=1512 Participants
|
41 Participants
n=504 Participants
|
81 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=1512 Participants
|
50 participants
n=504 Participants
|
100 participants
n=2016 Participants
|
|
ASA physical status
IV
|
6 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
|
Surgery type
Cardiac surgery
|
15 Participants
n=1512 Participants
|
7 Participants
n=504 Participants
|
22 Participants
n=2016 Participants
|
|
Surgery type
GI surgery
|
5 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Surgery type
Neurosurgery
|
7 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
|
Surgery type
Orthopedic surgery
|
23 Participants
n=1512 Participants
|
43 Participants
n=504 Participants
|
66 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: BaselineDifference between the average oropharyngeal oxygen saturation and the average extremity oxygen saturation which were recorded every 2 minutes for a total of 30 minutes.
Outcome measures
| Measure |
Palate
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
Tongue
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
|---|---|---|
|
Oropharyngeal vs Extremity Saturation
Extremity
|
98 percent of oxygen saturation
Interval 97.0 to 99.0
|
98 percent of oxygen saturation
Interval 97.0 to 99.0
|
|
Oropharyngeal vs Extremity Saturation
Oropharyngeal
|
95 percent of oxygen saturation
Interval 92.0 to 96.0
|
99 percent of oxygen saturation
Interval 97.0 to 100.0
|
PRIMARY outcome
Timeframe: BaselineThe arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording.
Outcome measures
| Measure |
Palate
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
Tongue
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
|---|---|---|
|
ABG PaO2
|
167 mmHg
Interval 135.0 to 210.0
|
237 mmHg
Interval 170.0 to 286.0
|
PRIMARY outcome
Timeframe: BaselineThe oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection.
Outcome measures
| Measure |
Palate
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
Tongue
n=50 Participants
The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.
Pulse oximetry: Noninvasive method of measuring the saturation of oxygen in the blood.
|
|---|---|---|
|
Oropharyngeal SpO2
|
100 percentage of oxygen saturation
Interval 99.8 to 100.0
|
100 percentage of oxygen saturation
Interval 100.0 to 100.0
|
Adverse Events
Palate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tongue
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