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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palate | Experimental | The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx. |
|
| Tongue | Experimental | The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximetry | Device | Noninvasive method of measuring the saturation of oxygen in the blood. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal vs Extremity Saturation | 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. | Baseline |
| ABG PaO2 | The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording. | Baseline |
| Oropharyngeal SpO2 | The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40742001 | Derived | Syed H, Villalobos EE, Kitio SAY, Hall B, Bryant J, Tobias JD. Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx. Paediatr Anaesth. 2025 Oct;35(10):816-821. doi: 10.1111/pan.70023. Epub 2025 Jul 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Tongue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oropharyngeal vs Extremity Saturation | 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. | Posted | Median | Inter-Quartile Range | percent of oxygen saturation | Baseline |
|
Day of surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Tobias | Nationwide Children's Hospital | 614-722-4200 | Joseph.Tobias@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | Apr 21, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2024 | Apr 21, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
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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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Inter-Quartile Range | centimeters |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| ASA physical status | The American Society of Anesthesiologists (ASA) Physical Status Classification System is a risk-stratifying system to help predict preoperative risks. ASA I - normal, healthy patient, ASA II - mild systemic disease without significant functional limitation, ASA III - one or more severe systemic diseases causing substantive functional limitation, ASA IV - severe systemic disease that poses a constant threat to life. | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
|
|
| Primary | ABG PaO2 | The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording. | Posted | Median | Inter-Quartile Range | mmHg | Baseline |
|
|
|
| Primary | Oropharyngeal SpO2 | The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection. | Posted | Median | Inter-Quartile Range | percentage of oxygen saturation | Baseline |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |