CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 105 enrolled
Drug / intervention
Oxygen (NRBM) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03840486
NCT03840486Phase 4Completed

Real Time Assessment of Pre-oxygenation Utilizing End-tidal Oxygen Measurements Versus Single Breath End-Tidal Oxygen Measurements in Healthy Volunteers

Emory University·interventional·Posted Feb 15, 2019·Updated Jun 13, 2025

In Brief

A Phase 4 clinical trial evaluating Non-rebreather mask (NRBM), Non-invasive ventilator mask (NIV), and 3 other interventions for Rapid Sequence Intubation. Completed, enrolled 105 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartSep 24, 2019
Primary CompletionOct 20, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.4 years ago

Interventions

Non-rebreather mask (NRBM)device

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).

Non-invasive ventilator mask (NIV)device

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.

Nasal cannula EtO2 sensordevice

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

Oxygen (NRBM)drug

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).

Oxygen (NIV)drug

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