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Completed

NCT Number: NCT03840486

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University Hospital Midtown, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 sensor

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Up to 3 minutes

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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