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

NCT03840486 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: IRB00100086
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Emergency department; Intubation; Pre-oxygenation

Outcome Measures

Primary Outcomes (1)

• 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.

  After each 3 minute treatment level

Secondary Outcomes (1)

• Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC)

  Up to 3 minutes

Study Arms (2)

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.

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.

Device: Non-invasive ventilator mask (NIV); Device: Nasal cannula EtO2 sensor; Drug: Oxygen (NIV)

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-rebreather mask (NRBM)

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.

Non-invasive ventilator mask (NIV)

Nasal cannula EtO2 sensor DEVICE

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

Non-invasive ventilator mask (NIV); Non-rebreather mask (NRBM)

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).

Non-rebreather mask (NRBM)

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.

Non-invasive ventilator mask (NIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Emergencies

Interventions

Oxygen; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Steven Lindsey, MD
• Organization: Emory University

steven.m.lindsey@emory.edu

913-706-0232

Study Officials

• Steven Lindsey, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: September 24, 2019
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)