Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients

NCT ID: NCT02219464

Last Updated: 2017-06-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Oxygen Administration During Deep Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nasopharyngeal catheter

Intervention Type DEVICE

Oxygen Supplementation

Intervention Type PROCEDURE

Initially set at 3 liters/minute

Sedation

Intervention Type PROCEDURE

Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol 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.

Group Type OTHER

Nasal Cannula

Intervention Type DEVICE

Oxygen Supplementation

Intervention Type PROCEDURE

Initially set at 3 liters/minute

Sedation

Intervention Type PROCEDURE

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

Interventions

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Nasopharyngeal catheter

Intervention Type DEVICE

Nasal Cannula

Intervention Type DEVICE

Oxygen Supplementation

Initially set at 3 liters/minute

Intervention Type PROCEDURE

Sedation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Bret Alvis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bret Alvis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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130627

Identifier Type: -

Identifier Source: org_study_id

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