Arterial Catheterization, Peripheral, Surgery
Conditions
Brief summary
This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.
Interventions
DEVICEPulse oximetry
Noninvasive method of measuring the saturation of oxygen in the blood.
Sponsors
Joseph D. Tobias
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula
Exclusion criteria
* Patients in whom an arterial cannula is not indicated for the surgical procedure * Patients in whom a peripheral pulse oximeter value cannot be obtained * Patients in whom an invasive arterial cannula cannot be placed * Patients with any type of intra-oral pathology or injury * Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal vs Extremity Saturation | Baseline | 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. |
| ABG PaO2 | Baseline | The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording. |
| Oropharyngeal SpO2 | Baseline | The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 100 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 12 years |
| ASA physical status I | 5 Participants |
| ASA physical status II | 27 Participants |
| ASA physical status III | 37 Participants |
| ASA physical status IV | 6 Participants |
| BMI | 21 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 150 centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 43 Participants |
| Surgery type Cardiac surgery | 7 Participants |
| Surgery type GI surgery | 5 Participants |
| Surgery type Neurosurgery | 0 Participants |
| Surgery type Orthopedic surgery | 66 Participants |
| Weight | 41 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
None listed