Phase 4
N=105
Pre-oxygenation With Real Time End-tidal Oxygen Measurements Versus Single Breath Measurements
Rapid Sequence Intubation
Bottom Line
View on ClinicalTrials.gov: NCT03840486 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Real Time and Single Breath End-tidal (EtO2) Measurements — 34; 63; 92; 58.5 percentage of end-tidal oxygen
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Non-rebreather mask (NRBM) (Device); Non-invasive ventilator mask (NIV) (Device); Nasal cannula EtO2 sensor (Device); Oxygen (NRBM) (Drug); Oxygen (NIV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Real Time and Single Breath End-tidal (EtO2) Measurements |
34; 63; 92; 58.5; 79; 87.5 | — |
| SECONDARY Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC) |
126; 100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults 18 years of age and older who are able to consent on their own without a legal representative
- Self-identified as being in good health
- Grossly normal dentition as judged by study investigators
- No self-reported symptoms of upper respiratory infection or other infectious process
- No history of severe pulmonary disease or asthma that requires daily use of an inhaler
- Females participants self-report to not be pregnant at time of study enrollment
- Study subjects will be recruited from within the Department of Emergency Medicine at Grady Memorial Hospital and Emory University Hospital Midtown. Study participants will be drawn from a pool that will include nursing staff, paramedical staff, students, residents, and attending physicians.
Exclusion Criteria
- Participant does not agree to study enrollment
- Participant cannot tolerate the entire course of non-invasive ventilation required to complete the study
- Participant does not agree to the video recording of the oxygen monitor to ensure proper data transcription
Data sourced from ClinicalTrials.gov (NCT03840486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.