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

• ClinicalTrials.gov Identifier: NCT03840486
• Recruitment Status: Suspended
• First Posted: February 15, 2019
• Last Update Posted: January 10, 2022
• Sponsor: Emory University
• Information provided by (Responsible Party): Steven Lindsey, Emory University

Study Description

Brief Summary:

The purpose of this study is to examine the ability of a nasal cannula sensor to predict end-tidal oxygen levels in real time.

Condition or disease	Intervention/treatment	Phase
Pre-oxygenation	Device: Non-rebreather mask (NRBM); Device: Non-invasive ventilator mask (NIV); Device: Nasal cannula EtO2 sensor; Drug: Oxygen (NRBM); Drug: Oxygen (NIV)	Phase 4

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. Different methods of pre-oxygenation have been studied by taking a single breath end-tidal oxygen (EtO2) measurement with higher levels indicating more complete pre-oxygenation. However, there has not been any research examining methods of determining the quality of pre-oxygenation in real time. This study examines the performance of a nasal cannula EtO2 measurement as compared to the gold standard of single breath end-tidal oxygen measurements in healthy volunteers.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Real Time Assessment of Pre-oxygenation Utilizing End-tidal Oxygen Measurements Versus Single Breath End-Tidal Oxygen Measurements in Healthy Volunteers
• Actual Study Start Date: September 24, 2019
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Non-rebreather mask (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 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); 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 (Liter per minute), 35 LPM, or Flush rate at 55 LPM).; Device: 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 (Liter per minute), 35 LPM, or flush rate at 55 LPM).
Active Comparator: Non-invasive ventilator mask (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 50% FiO2 for 3 minutes, NIV at 75% 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); 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.; Device: 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 (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.

Outcome Measures

Primary Outcome Measures :

1. Degree of correlation between real time and single breath EtO2 measurements [ Time Frame: At 3 minutes ]
   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.

Secondary Outcome Measures :

1. Correlation of EtO2 between the nasal cannula and single breath sensors [ Time Frame: At 3 minutes ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Adults 18 years of age and older who are able to consent on their own without a legal representative (ability to consent)
• Self-identified as being in good health (ensuring healthy volunteers)
• Grossly normal dentition as judged by study investigators (may affect NIV mask seal)
• No history of severe pulmonary disease or asthma that requires daily use of an inhaler (ensuring healthy volunteers)
• Females participants only: Self-reported to not be pregnant at time of study enrollment (for protection of an unborn child)

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

Contacts and Locations

Locations

United States, Georgia

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Sponsors and Collaborators

Emory University

Investigators

• Principal Investigator: Stephen Carroll, DO, MEd, FACEP; Emory University

More Information

• Responsible Party: Steven Lindsey, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03840486
• Other Study ID Numbers: IRB00100086
• First Posted: February 15, 2019
• Last Update Posted: January 10, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No