Rapid Sequence Intubation
Conditions
Keywords
Emergency department, Intubation, Pre-oxygenation
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.
Interventions
DEVICENon-invasive ventilator mask (NIV)
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.
DEVICENasal cannula EtO2 sensor
The nasal cannula EtO2 sensor will be placed on the participant's face under the mask to detect the EtO2 levels.
DEVICENon-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).
DRUGOxygen (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).
DRUGOxygen (NIV)
Oxygen will be delivered via the NIV mask. Participants will receive oxygen at 40% FiO2, 70% FiO2 or 100% FiO2 for 3 minutes each.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real Time and Single Breath End-tidal (EtO2) Measurements | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at Grady Memorial Hospital and Emory University Hospital Midtown in Atlanta, Georgia, USA. Participant enrollment began September 24, 2019 and the final study assessment occurred on October 20, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Non-invasive Ventilator Mask (NIV) Prior to the start of the study procedure, a nasal cannula end-tidal oxygen (EtO2) sensor was placed on the participant's face with the non-invasive ventilator mask (NIV) overlying the sensor. Participants were randomized to the order of their treatment sequence to one of six combinations of 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 each trial was recorded. The study participants were allowed to rest until their EtO2 returned to their baseline, then they were 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. | 52 |
| Non-rebreather Mask (NRBM) Prior to the start of the study procedure, a nasal cannula end-tidal oxygen (EtO2) sensor was placed on the participant's face with the non-rebreather mask (NRBM) overlying the sensor. The participants were randomized to the order of their treatment sequence to one of six combinations of 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 each trial was recorded, then the study subjects were allowed to rest until their EtO2 returned to their baseline. They were then 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. | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Non-invasive Ventilator Mask (NIV) | Non-rebreather Mask (NRBM) | Total |
|---|---|---|---|
| Age, Continuous | 28 years | 27 years | 28 years |
| Baseline Single Breath End Tidal Oxygen (EtO2%) | 16.8 percent of oxygenation | 16.8 percent of oxygenation | 16.8 percent of oxygenation |
| Body Mass Index (BMI) | 24.7 kg/m^2 | 24.9 kg/m^2 | 24.8 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 52 participants | 52 participants | 104 participants |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 67 Participants |
| Sex: Female, Male Male | 22 Participants | 15 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 53 | 0 / 52 | 0 / 52 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 53 | 0 / 52 | 0 / 52 | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 | 0 / 52 | 0 / 52 | 0 / 52 | 0 / 52 |
Outcome results
Primary
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.
Time frame: After each 3 minute treatment level
Population: This analysis includes participants who completed all three intervention levels.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NIV at 40% FiO2 | Real Time and Single Breath End-tidal (EtO2) Measurements | Single-breath end-tidal oxygen measurement | 33.1 percentage of end-tidal oxygen |
| NIV at 40% FiO2 | Real Time and Single Breath End-tidal (EtO2) Measurements | Nasal cannula end-tidal oxygen measurement | 34 percentage of end-tidal oxygen |
| NIV at 70% FiO2 | Real Time and Single Breath End-tidal (EtO2) Measurements | Nasal cannula end-tidal oxygen measurement | 63 percentage of end-tidal oxygen |
| NIV at 70% FiO2 | Real Time and Single Breath End-tidal (EtO2) Measurements | Single-breath end-tidal oxygen measurement | 58.4 percentage of end-tidal oxygen |
| NIV at 100% FiO2 | Real Time and Single Breath End-tidal (EtO2) Measurements | Nasal cannula end-tidal oxygen measurement | 92 percentage of end-tidal oxygen |
| NIV at 100% FiO2 | Real Time and Single Breath End-tidal (EtO2) Measurements | Single-breath end-tidal oxygen measurement | 84.6 percentage of end-tidal oxygen |
| NRBM at 15 LPM | Real Time and Single Breath End-tidal (EtO2) Measurements | Nasal cannula end-tidal oxygen measurement | 58.5 percentage of end-tidal oxygen |
| NRBM at 15 LPM | Real Time and Single Breath End-tidal (EtO2) Measurements | Single-breath end-tidal oxygen measurement | 44.9 percentage of end-tidal oxygen |
| NRBM at 35 LPM | Real Time and Single Breath End-tidal (EtO2) Measurements | Nasal cannula end-tidal oxygen measurement | 79 percentage of end-tidal oxygen |
| NRBM at 35 LPM | Real Time and Single Breath End-tidal (EtO2) Measurements | Single-breath end-tidal oxygen measurement | 60.8 percentage of end-tidal oxygen |
| NRBM at 55 LPM | Real Time and Single Breath End-tidal (EtO2) Measurements | Single-breath end-tidal oxygen measurement | 70.5 percentage of end-tidal oxygen |
| NRBM at 55 LPM | Real Time and Single Breath End-tidal (EtO2) Measurements | Nasal cannula end-tidal oxygen measurement | 87.5 percentage of end-tidal oxygen |
Secondary
Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC)
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.
Time frame: Up to 3 minutes
Population: This analysis includes participants who completed all three intervention levels.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NIV at 40% FiO2 | Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC) | 126 seconds |
| NIV at 70% FiO2 | Time to Maximum End-tidal Oxygen (EtO2) Nasal Cannula Measurement (TmaxNC) | 100 seconds |