An interventional study of Nasopharyngeal catheter and Nasal Cannula in Oxygen Administration During Deep Sedation, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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.
Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
Device: Nasopharyngeal catheter · Procedure: Oxygen Supplementation · Procedure: Sedation
Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Device: Nasal Cannula · Procedure: Oxygen Supplementation · Procedure: Sedation
Initially set at 3 liters/minute
Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.
Number of Participants With Oxygen Saturations Below 92%
Time frame: During surgical procedure
Number of Participants Who Needed Airway Assistance Interventions
(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).
Time frame: During surgical procedure
| Milestone | Nasopharyngeal Catheter | Nasal Cannula |
|---|---|---|
| Started | 30 | 30 |
| Completed | 27 | 30 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Case cancelled | 1 | 0 |
| Withdrew: Catheter malfunction | 1 | 0 |
| Participants | Nasopharyngeal Catheter | Nasal Cannula |
|---|---|---|
| Number of Participants With Oxygen Saturations Below 92% | 3 | 12 |
(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).
| Participants | Nasopharyngeal Catheter | Nasal Cannula |
|---|---|---|
| Number of Participants Who Needed Airway Assistance Interventions | 4 | 17 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nasopharyngeal Catheter | 0/27 (0%) | 0/27 (0%) | 1/26 (3.8%) |
| Nasal Cannula | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Event | Nasopharyngeal Catheter | Nasal Cannula |
|---|---|---|
| Nose BleedInjury, poisoning and procedural complications | 1/26 | 0/30 |
| Age, Categorical(Participants) | Nasopharyngeal Catheter | Nasal Cannula | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 20 | 39 |
| >=65 years | 8 | 10 | 18 |
| Sex: Female, Male(Participants) | Nasopharyngeal Catheter | Nasal Cannula | Total |
|---|---|---|---|
| Female | 12 | 14 | 26 |
| Male | 15 | 16 | 31 |
| Race and Ethnicity Not Collected(Participants) | Nasopharyngeal Catheter | Nasal Cannula | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Nasopharyngeal Catheter | Nasal Cannula | Total |
|---|---|---|---|
| United States | 27 | 30 | 57 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Vanderbilt University