NCT02219464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

August 12, 2014

Results QC Date

February 3, 2017

Last Update Submit

May 26, 2017

Conditions

Oxygen Administration During Deep Sedation

Keywords

nasopharyngeal catheternasal cannula

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Oxygen Saturations Below 92%

    During surgical procedure

Secondary Outcomes (1)

  • Number of Participants Who Needed Airway Assistance Interventions

    During surgical procedure

Study Arms (2)

Nasopharyngeal catheter

ACTIVE COMPARATOR

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 catheterProcedure: Oxygen SupplementationProcedure: Sedation

Nasal Cannula

OTHER

Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.

Device: Nasal CannulaProcedure: Oxygen SupplementationProcedure: Sedation

Interventions

Nasopharyngeal catheterDEVICE
Nasopharyngeal catheter
Nasal CannulaDEVICE
Nasal Cannula
Oxygen SupplementationPROCEDURE

Initially set at 3 liters/minute

Nasal CannulaNasopharyngeal catheter
SedationPROCEDURE

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

Nasal CannulaNasopharyngeal catheter

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Cannula

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Results Point of Contact

Title
Cindy Pastern, RN BSN CCRP
Organization
Vanderbilt University Medical Center
cindy.pastern@vanderbilt.edu
615-343-0259

Study Officials

  • Bret Alvis, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 19, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

June 1, 2017

Results First Posted

June 1, 2017

Record last verified: 2016-05

Locations

US(1)