Clinical trial NCT03840486: Pre-oxygenation With Real Time End-tidal Oxygen Measurements Versus Single Breath Measurements
Official title: Real Time Assessment of Pre-oxygenation Utilizing End-tidal Oxygen Measurements Versus Single Breath End-Tidal Oxygen Measurements in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rapid Sequence Intubation
Keywords: Emergency department
Intubation
Pre-oxygenation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Real Time and Single Breath End-tidal (EtO2) Measurements
timeFrame: After each 3 minute treatment level
Secondary outcomes:
measure: Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC)
timeFrame: Up to 3 minutes
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Steven Lindsey, MD
role: PRINCIPAL_INVESTIGATOR
References: