Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients

Not Applicable

Completed

• Conditions: Oxygen Administration During Deep Sedation
• Interventions: Device: Nasal Cannula; Device: Nasopharyngeal catheter; Procedure: Oxygen Supplementation; Procedure: Sedation

• Registration Number: NCT02219464
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-19
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-05
• Results First Submitted: 2017-02-03
• Results First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Results First Posted: 2017-06-01
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Cannula	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	Sedation	Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Nasopharyngeal catheter	Oxygen Supplementation	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	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	Sedation	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	Oxygen Supplementation	Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Oxygen Saturations Below 92%	During surgical procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Needed Airway Assistance Interventions	During surgical procedure	(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States