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The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under moderate sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasopharyngeal catheter | Active Comparator | Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups. |
|
| Nasal Cannula | Other | Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal catheter | Device |
| ||
| Nasal Cannula |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Oxygen Saturations Below 92% | During surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Needed Airway Assistance Interventions | (jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.). | During surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bret Alvis, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasopharyngeal Catheter | Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups. Nasopharyngeal catheter Oxygen Supplementation: Initially set at 4 liters/minute Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist. |
| FG001 | Nasal Cannula | Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups. Nasal Cannula Oxygen Supplementation: Initially set at 4 liters/minute Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasopharyngeal Catheter | Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups. Nasopharyngeal catheter Oxygen Supplementation: Initially set at 4 liters/minute Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist. |
| 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 | Number of Participants With Oxygen Saturations Below 92% | Posted | Count of Participants | Participants | During surgical procedure |
|
Adverse events were monitoring for the entire procedure all the way through the patients discharge from the post-anesthesia care unit. This would average around 4 hours of time; however, no time limit was placed on our adverse event monitoring. Once the procedure started to the point they were taken to their form of transportation, each subject was monitored for an adverse event.
The data collection individual would report to the primary investigator and submit report to the Vanderbilt University Institution Review Board.
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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 | Nasopharyngeal Catheter | Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups. Nasopharyngeal catheter Oxygen Supplementation: Initially set at 4 liters/minute Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nose Bleed | Injury, poisoning and procedural complications | Other | Systematic Assessment | Nose Bleed from NasoPharyngeal Catheter Placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy Pastern, RN BSN CCRP | Vanderbilt University Medical Center | 615-343-0259 | cindy.pastern@vanderbilt.edu |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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| Oxygen Supplementation | Procedure | Initially set at 3 liters/minute |
|
| Sedation | Procedure | Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist. |
|
| catheter malfunction |
|
| BG001 | Nasal Cannula | Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups. Nasal Cannula Oxygen Supplementation: Initially set at 4 liters/minute Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants Who Needed Airway Assistance Interventions | (jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.). | Posted | Count of Participants | Participants | During surgical procedure |
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| 0 |
| 27 |
| 0 |
| 27 |
| 1 |
| 26 |
| EG001 | Nasal Cannula | Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups. Nasal Cannula Oxygen Supplementation: Initially set at 4 liters/minute Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist. | 0 | 30 | 0 | 30 | 0 | 30 |
|
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