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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840486
Recruitment Status : Suspended (Study is temporarily suspended due to COVID-19.)
First Posted : February 15, 2019
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Stephen Carroll DO, Emory University

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.

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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 : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840486


Locations
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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Stephen Carroll, DO, MEd, FACEP Emory University
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Responsible Party: Stephen Carroll DO, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03840486    
Other Study ID Numbers: IRB00100086
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020

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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