Trial Outcomes & Findings for Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients (NCT NCT02219464)

NCT ID: NCT02219464

Last Updated: 2017-06-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: During surgical procedure
• Results posted on: 2017-06-01

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	27	30
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	0
Overall Study case cancelled	1	0
Overall Study catheter malfunction	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Nasopharyngeal Catheter n=27 Participants 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.	Nasal Cannula n=30 Participants 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.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=30 Participants	0 Participants n=57 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=27 Participants	20 Participants n=30 Participants	39 Participants n=57 Participants
Age, Categorical >=65 years	8 Participants n=27 Participants	10 Participants n=30 Participants	18 Participants n=57 Participants
Sex: Female, Male Female	12 Participants n=27 Participants	14 Participants n=30 Participants	26 Participants n=57 Participants
Sex: Female, Male Male	15 Participants n=27 Participants	16 Participants n=30 Participants	31 Participants n=57 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	27 participants n=27 Participants	30 participants n=30 Participants	57 participants n=57 Participants

PRIMARY outcome

Timeframe: During surgical procedure

Outcome measures

Measure	Nasopharyngeal Catheter n=27 Participants 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.	Nasal Cannula n=30 Participants 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.
Number of Participants With Oxygen Saturations Below 92%	3 Participants	12 Participants

SECONDARY outcome

Timeframe: During surgical procedure

(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).

Outcome measures

Measure	Nasopharyngeal Catheter n=27 Participants 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.	Nasal Cannula n=30 Participants 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.
Number of Participants Who Needed Airway Assistance Interventions	4 Participants	17 Participants

Adverse Events

Nasopharyngeal Catheter

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nasal Cannula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nasopharyngeal Catheter n=26 participants at risk；n=27 participants at risk 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.	Nasal Cannula n=30 participants at risk 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.
Injury, poisoning and procedural complications Nose Bleed	3.8% 1/26 • Number of events 1 • 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.	0.00% 0/30 • 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.

Additional Information

Cindy Pastern, RN BSN CCRP

Vanderbilt University Medical Center

Phone: 615-343-0259

Email: cindy.pastern@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place