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Pre-oxygenation With Real Time End-tidal Oxygen Measurements Versus Single Breath Measurements

NCT03840486 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-06-13

Study results available
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Summary

This study examines the performance of a nasal cannula end-tidal oxygen (EtO2) measurement as compared to the gold standard of single breath end-tidal oxygen measurements in healthy volunteers. The purpose of this study is to examine the ability of each sensor to predict oxygen levels in real time.

Conditions

  • Rapid Sequence Intubation

Interventions

DEVICE

Non-rebreather mask (NRBM)

The non-rebreather mask (NRBM) will be used to assist in the delivery of oxygen. Participants will be placed on NRBM at different flow rates (15 LPM, 35 LPM, or Flush rate at 55 LPM).

DEVICE

Non-invasive ventilator mask (NIV)

The NIV is a non-invasive face (nasal) mask for oxygen delivery. Participants will receive oxygen at 40% FiO2 for 3 minutes, 70% FiO2 for 3 minutes or 100% FiO2 for 3 minutes each.

DEVICE

Nasal cannula EtO2 sensor

The nasal cannula EtO2 sensor will be placed on the participant's face under the mask to detect the EtO2 levels.

DRUG

Oxygen (NRBM)

Oxygen will be delivered via the NRBM. Participants will receive oxygen at different flow rates (15 LPM, 35 LPM, or flush rate at 55 LPM).

DRUG

Oxygen (NIV)

Oxygen will be delivered via the NIV mask. Participants will receive oxygen at 40% FiO2, 70% FiO2 or 100% FiO2 for 3 minutes each.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Steven Lindsey, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2023-10-20
Completion
2023-10-20
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03840486 on ClinicalTrials.gov