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

Rapid Sequence Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840486
• Other study ID #: IRB00100086
• Status: Completed
• Phase: Phase 4
• Start date: September 24, 2019
• Est. completion date: October 20, 2023

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rapid Sequence Intubation

Intervention

Device:
• 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).
• Non-invasive ventilator mask (NIV)
The NIV is a non-invasive face (nasal) mask for oxygen delivery. Participants will receive oxygen at 50% FiO2 for 3 minutes, 75% FiO2 for 3 minutes or 100% FiO2 for 3 minutes each.
• Nasal cannula EtO2 sensor
The nasal cannula EtO2 sensor will be placed on the participant's face under the mask to detect the EtO2 levels.

Drug:
• 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).
• Oxygen (NIV)
Oxygen will be delivered via the NIV mask. Participants will receive oxygen at 50% FiO2, 75% FiO2 or 100% FiO2 for 3 minutes each.

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of correlation between real time and single breath EtO2 measurements	The degree of correlation between real time EtO2 measurements and a single breath end-tidal oxygen measurement as measured by the k correlation coefficient will be done at the end of 3 minutes. Correlation coefficients are expressed as values between +1 and -1 and is a statistical measure of the degree to which changes to the value of one variable predict change to the value of the other.	At 3 minutes
Secondary	Correlation of EtO2 between the nasal cannula and single breath sensors	The correlation of EtO2 between the nasal cannula sensor and the single breath sensor once stabilized at maximal readings as measured by the k correlation coefficient will be done at the end of 3 minutes. Correlation coefficients are expressed as values between +1 and -1 and is a statistical measure of the degree to which changes to the value of one variable predict change to the value of the other.	At 3 minutes