Rapid Sequence IntubationPhase 4NCT03840486

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

A Phase 4 study testing Non-rebreather mask (NRBM), Non-invasive ventilator mask (NIV) and Nasal cannula EtO2 sensor in people with Rapid Sequence Intubation, run by Emory University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Rapid Sequence Intubation
What is being tested?: Non-rebreather mask (NRBM), Non-invasive ventilator mask (NIV) and Nasal cannula EtO2 sensor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 2 sitesUnited States
Study dates: 24 Sep 2019to 20 Oct 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308

Other trials in United States

About this study

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

Read the detailed description

Patients in the Emergency Department (ED) undergoing Rapid Sequence Intubation (RSI) are at risk for serious morbidity and mortality. In order to provide oxygen during the apneic period, it is common practice to provide pre-oxygenation prior to the start of the procedure with high flows of oxygen. Techniques commonly employed to pre-oxygenate ED patients undergoing RSI include high flow oxygen via a non-rebreather mask (NRBM), a self-inflating bag-valve mask (BVM), or non-invasive ventilation (NIV). However, there are currently no studies that explore how to assess the quality of a patient's pre-oxygenation in real time prior to intubation.

Several recent studies that have assessed the use of single breath end-tidal oxygen to assess the effectiveness of various oxygenation strategies. Typically, healthy volunteers are placed on 2 to 3 minutes of a certain pre-oxygenation strategy followed by exhalation of a single breath into an end-tidal oxygen sensor. Higher end-tidal oxygen measurements are used as a marker for pre-oxygenation with higher percentages indicating more complete pre-oxygenation.

A goal EtO2 reading of 90% is typically used to indicate maximal pre-oxygenation. However, this method of assessing pre-oxygenation would be impractical in actual ED patients who are critically ill and may not be able to fully participate in such a measurement. In addition, discontinuing a pre-oxygenation method to obtain a single breath EtO2 reading would be unethical as it would interfere with proper pre-oxygenation in a critically ill patient. A better method would be to examine end-tidal oxygen measurements from patients in real-time as they are being pre-oxygenated. This study will examine the use of a real time nasal cannula EtO2 sensor as compared to the gold standard of a single breath exhalation into a static sensor.

Healthy participants will be randomly assigned to use the non-rebreather mask or the non-invasive ventilator. A baseline EtO2 measurement will be obtained with the nasal cannula EtO2 sensor then the mask the participant was randomized to use will be placed over the nasal cannula EtO2 sensor and oxygenation trials will begin. At the end of each trial a single breath end-tidal oxygen measurement will be obtained.

Conditions: Rapid Sequence Intubation
Being tested: Non-rebreather mask (NRBM), Non-invasive ventilator mask (NIV), Nasal cannula EtO2 sensor, Oxygen (NRBM), Oxygen (NIV)
Keywords: Emergency department, Intubation, Pre-oxygenation
Medical subject headings: Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03840486
Study group	Role	What they receive
Non-rebreather mask (NRBM)	Active comparator	Prior to the start of the study procedure, a nasal cannula end-tidal oxygen (EtO2) sensor will be placed on the participant's face with the non-rebreather mask (NRBM) overlying the sensor. The participants will be randomized to the order of their treatment sequence as follows: oxygen at 15 liters per minute (LPM) for 3 minutes, at 35 LPM for 3 minutes, or at flush rate (55 LPM) for 3 minutes. The maximal reading at the end of this will be recorded, then the study subjects will be allowed to rest until their EtO2 returns to their baseline. They will then be placed back on NRBM at flush rate, allowed to rise to the maximal reading of the previous step, then do a single breath exhaled EtO2 measurement. Receives: Device: Non-rebreather mask (NRBM); Device: Nasal cannula EtO2 sensor; Drug: Oxygen (NRBM)
Non-invasive ventilator mask (NIV)	Active comparator	Prior to the start of the study procedure, a nasal cannula end-tidal oxygen (EtO2) sensor will be placed on the participant's face with the non-invasive ventilator mask (NIV) overlying the sensor. Participants will be randomized to the order of their treatment sequence as follows: NIV at 40% fraction of inspired oxygen (FiO2) for 3 minutes, NIV at 70% FiO2 for 3 minutes, NIV at 100% FiO2 for 3 minutes, the maximal reading at the end of this trial will be recorded. The study subjects will be allowed to rest until their EtO2 returns to their baseline, then they will be placed back on NIV at 100% FiO2, allowed to rise to the maximal reading of the previous step, then do a single breath exhaled EtO2 measurement. Receives: Device: Non-invasive ventilator mask (NIV); Device: Nasal cannula EtO2 sensor; Drug: Oxygen (NIV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Real Time and Single Breath End-tidal (EtO2) Measurements
Real-time end-tidal oxygen measurements as measured with a nasal cannula (NC) and single-breath (SB) end-tidal oxygen measurements across increasing oxygen concentrations and flow rates for the non-invasive ventilation (NIV) and non-rebreather mask (NRBM) study arms.
Measured: After each 3 minute treatment level

Secondary outcomes (1)

Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC)
Time required to reach 3-minute nasal cannula end-tidal oxygen (EtO2) reading for the single-breath (SB) EtO2 measurement at TmaxNC for the non-invasive ventilation (NIV) and non-rebreather mask (NRBM) arms.
Measured: Up to 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201920 Oct 2023

First posted15 Feb 2019
Study start24 Sep 2019
Primary completion20 Oct 2023
Study completion20 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rapid Sequence IntubationStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03840486
Sponsor's protocol ID: IRB00100086
Status last verified: May 2025
First submitted: 12 Feb 2019
Last updated: 13 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Propofol or Esketamine: Tracheal Intubation Comparison
Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit
Recruiting
Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.
Intubation in Intensive Care Units
Enrolling by invitationObservational study
Effect of Ketamine and Etomidate During RSI on Long Term Outcomes
Post-Traumatic Stress Disorder, Acute Respiratory Failure
RecruitingObservational study
Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
Critical Illness
Not yet recruiting
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management

All Rapid Sequence Intubation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real Time Assessment of Pre-oxygenation Utilizing End-tidal Oxygen Measurements Versus Single Breath End-Tidal Oxygen Measurements in Healthy Volunteers
ClinicalTrials.gov ID: NCT03840486
Acronym / sponsor ID: IRB00100086
Conditions: Rapid Sequence Intubation
Keywords: Emergency department, Intubation, Pre-oxygenation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 24 Sep 2019 (actual)
Primary completion: 20 Oct 2023 (actual)
Study completion: 20 Oct 2023 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 13 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Non-rebreather mask (NRBM)	Active comparator	Device: Non-rebreather mask (NRBM), Device: Nasal cannula EtO2 sensor, Drug: Oxygen (NRBM)Prior to the start of the study procedure, a nasal cannula end-tidal oxygen (EtO2) sensor will be placed on the participant's face with the non-rebreather mask (NRBM) overlying the sensor. The participants will be randomized to the order of their treatment sequence as follows: oxygen at 15 liters per minute (LPM) for 3 minutes, at 35 LPM for 3 minutes, or at flush rate (55 LPM) for 3 minutes. The maximal reading at the end of this will be recorded, then the study subjects will be allowed to rest until their EtO2 returns to their baseline. They will then be placed back on NRBM at flush rate, allowed to rise to the maximal reading of the previous step, then do a single breath exhaled EtO2 measurement.
Non-invasive ventilator mask (NIV)	Active comparator	Device: Non-invasive ventilator mask (NIV), Device: Nasal cannula EtO2 sensor, Drug: Oxygen (NIV)Prior to the start of the study procedure, a nasal cannula end-tidal oxygen (EtO2) sensor will be placed on the participant's face with the non-invasive ventilator mask (NIV) overlying the sensor. Participants will be randomized to the order of their treatment sequence as follows: NIV at 40% fraction of inspired oxygen (FiO2) for 3 minutes, NIV at 70% FiO2 for 3 minutes, NIV at 100% FiO2 for 3 minutes, the maximal reading at the end of this trial will be recorded. The study subjects will be allowed to rest until their EtO2 returns to their baseline, then they will be placed back on NIV at 100% FiO2, allowed to rise to the maximal reading of the previous step, then do a single breath exhaled EtO2 measurement.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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-rebreather mask (NRBM)
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	Non-invasive ventilator mask (NIV)
Nasal cannula EtO2 sensorThe nasal cannula EtO2 sensor will be placed on the participant's face under the mask to detect the EtO2 levels.	Device	Non-invasive ventilator mask (NIV), Non-rebreather mask (NRBM)
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	Non-rebreather mask (NRBM)
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.	Drug	Non-invasive ventilator mask (NIV)

Primary outcome

Real Time and Single Breath End-tidal (EtO2) Measurements
Time frame: After each 3 minute treatment level
Real-time end-tidal oxygen measurements as measured with a nasal cannula (NC) and single-breath (SB) end-tidal oxygen measurements across increasing oxygen concentrations and flow rates for the non-invasive ventilation (NIV) and non-rebreather mask (NRBM) study arms.

1 secondary outcome

Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC)
Time frame: Up to 3 minutes

Results and safety

Results posted to the registry on 13 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NIV With Delivery Sequence of NIV at 40% FiO2, NIV at 70% FiO2, and NIV at 100% FiO2	7	7
NIV With Delivery Sequence of NIV at 70% FiO2, 40% FiO2, and 100% FiO2	11	10
NIV With Delivery Sequence of NIV at 100% FiO2, NIV at 70% FiO2, and NIV at 40% FiO2	10	10
NIV With Delivery Sequence of NIV at 40% FiO2, NIV at 100% FiO2, and NIV at 70% FiO2	9	9
NIV With Delivery Sequence of NIV at 70% FiO2, NIV at 100% FiO2, and NIV at 40% FiO2	8	8
NIV With Delivery Sequence of NIV at 100% FiO2, NIV at 40% FiO2, and NIV at 70% FiO2	8	8
NRBM With Delivery Sequence of Oxygen at 15 LPM, 35 LPM, and 55 LPM	8	8
NRBM With Delivery Sequence of Oxygen at 15 LPM, 55 LPM, and 35 LPM	9	9
NRBM With Delivery Sequence of Oxygen at 35 LPM, 55 LPM, and 15 LPM	8	8
NRBM With Delivery Sequence of Oxygen at 35 LPM, 15 LPM, and 55 LPM	9	9
NRBM With Delivery Sequence of Oxygen at 55 LPM, 35 LPM, and 15 LPM	9	9
NRBM With Delivery Sequence of Oxygen at 55 LPM, 15 LPM, and 35 LPM	9	9

Primary outcome: Real Time and Single Breath End-tidal (EtO2) Measurements

Time frame: After each 3 minute treatment level. Median (Inter-Quartile Range). Unit: percentage of end-tidal oxygen

Measure	NIV at 40% FiO2 n = 52	NIV at 70% FiO2 n = 52	NIV at 100% FiO2 n = 52	NRBM at 15 LPM n = 52	NRBM at 35 LPM n = 52	NRBM at 55 LPM n = 52
Nasal cannula end-tidal oxygen measurement	34 (33 to 35.8)	63 (61 to 64)	92 (91 to 93)	58.5 (48.3 to 66)	79 (72.3 to 84.8)	87.5 (83 to 91)
Single-breath end-tidal oxygen measurement	33.1 (29.9 to 34.6)	58.4 (52.2 to 61.5)	84.6 (73.7 to 88.1)	44.9 (38.7 to 50.1)	60.8 (51.4 to 69.4)	70.5 (60.3 to 82.1)

Population analysed: This analysis includes participants who completed all three intervention levels.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Information on adverse events was collected beginning at the time of the intervention and continuing through the end of the intervention, on Day 1 of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NIV at 40% FiO2	0 of 52 (0%)	0 of 52 (0%)	0 of 52
NIV at 70% FiO2	0 of 53 (0%)	0 of 53 (0%)	0 of 53
NIV at 100% FiO2	0 of 52 (0%)	0 of 52 (0%)	0 of 52
NRBM at 15 LPM	0 of 52 (0%)	0 of 52 (0%)	0 of 52
NRBM at 35 LPM	0 of 52 (0%)	0 of 52 (0%)	0 of 52
NRBM at 55 LPM	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Rapid Sequence Intubation

Not yet recruitingPhase 4
Propofol or Esketamine: Tracheal Intubation Comparison
Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit
Recruiting
Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.
Intubation in Intensive Care Units
Enrolling by invitationObservational study
Effect of Ketamine and Etomidate During RSI on Long Term Outcomes
Post-Traumatic Stress Disorder, Acute Respiratory Failure
RecruitingObservational study
Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
Critical Illness
Not yet recruiting
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Lindsey, MD principal investigator

Emory University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real Time and Single Breath End-tidal (EtO2) Measurements (time frame: After each 3 minute treatment level). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.