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Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients

Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02219464
Enrollment
60
Registered
2014-08-19
Start date
2014-08-31
Completion date
2016-01-31
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Administration During Deep Sedation

Keywords

nasopharyngeal catheter, nasal cannula

Brief summary

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.

Interventions

DEVICENasopharyngeal catheter
DEVICENasal Cannula
PROCEDUREOxygen Supplementation

Initially set at 3 liters/minute

PROCEDURESedation

Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients greater than 16 years of age * Patients who present for oral surgery or esophagoduodenography and colonoscopy * Patients who undergo intravenous sedation

Exclusion criteria

* Patients who require endotracheal intubation * ASA class 4 or higher * Existing esophageal disease such as a perforation or varices

Design outcomes

Primary

MeasureTime frame
Number of Participants With Oxygen Saturations Below 92%During surgical procedure

Secondary

MeasureTime frameDescription
Number of Participants Who Needed Airway Assistance InterventionsDuring surgical procedure(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
27
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.
30
Total57

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studycase cancelled10
Overall Studycatheter malfunction10
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicNasal CannulaTotalNasopharyngeal Catheter
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants18 Participants8 Participants
Age, Categorical
Between 18 and 65 years
20 Participants39 Participants19 Participants
Race and Ethnicity Not Collected—0 Participants—
Region of Enrollment
United States
30 participants57 participants27 participants
Sex: Female, Male
Female
14 Participants26 Participants12 Participants
Sex: Female, Male
Male
16 Participants31 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 30
other
Total, other adverse events
1 / 260 / 30
serious
Total, serious adverse events
0 / 270 / 30

Outcome results

Primary

Number of Participants With Oxygen Saturations Below 92%

Time frame: During surgical procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nasopharyngeal CatheterNumber of Participants With Oxygen Saturations Below 92%3 Participants
Nasal CannulaNumber of Participants With Oxygen Saturations Below 92%12 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nasopharyngeal CatheterNumber of Participants Who Needed Airway Assistance Interventions4 Participants
Nasal CannulaNumber of Participants Who Needed Airway Assistance Interventions17 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026