NCT04979533

Brief Summary

The purpose of this project is to evaluate the efficacy of oxygen insufflation (continuous oxygen flow) to keep oxygen saturation (oxygen levels measured with a pulse oximeter \[finger device used in medicine\]) at 90% or greater in adult patients undergoing microlaryngoscopy surgery.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 29, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

June 29, 2021

Last Update Submit

January 24, 2023

Conditions

Hypoxia

Keywords

surgeryairwayhypoxia preventionoxygen insufflation

Outcome Measures

Primary Outcomes (1)

  • High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures

    15 liters per minute of oxygen will be administered to the posterior oropharynx.

    30-60 minutes

Secondary Outcomes (2)

  • Degree of hypercapnia experienced by participants

    30-60 minutes

  • Participants That Maintain Adequate Oxygenation at 90% or Greater

    30-60 minutes

Study Arms (1)

Oxygen Insufflation

EXPERIMENTAL

Oxygen insufflation via oxygen tubing at 15 L/min

Device: Insufflator oxygen tubing

Interventions

Insufflator oxygen tubingDEVICE

high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.

Also known as: Flexible Oxygen tubing
Oxygen Insufflation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing microlaryngoscopy surgery without a tracheostomy

You may not qualify if:

  • patients who have a tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hollie N Sanders, MSN

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: There will be a single group of participants in which all receive oxygen insufflation to see if oxygen insufflation is adequate in microlaryngoscopy airway surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Certified Registered Nurse Anesthetist

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 28, 2021

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 30, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

The oxygen saturation numbers throughout each surgery will be recorded with no personal identifying data of each patient.