Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients

May 26, 2017 updated by: Bret Alvis, Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Nasopharyngeal catheter
Procedure: Oxygen Supplementation
Initially set at 3 liters/minute
Procedure: Sedation
Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.
Other: Nasal Cannula
Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Procedure: Oxygen Supplementation
Initially set at 3 liters/minute
Procedure: Sedation
Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.
Device: Nasal Cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Oxygen Saturations Below 92%
Time Frame: During surgical procedure
During surgical procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Bret Alvis, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 130627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oxygen Administration During Deep Sedation

Clinical Trials on Nasopharyngeal catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe