End-Tidal Oxygen Monitoring for Preventing Hypoxia

(PREOXED Trial)

Recruiting at 9 trial locations

Overseen By Naomi Derrick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sydney Local Health District

Disqualifiers: Under 18, Pregnant, Prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an End-Tidal Oxygen Monitor (a device for measuring oxygen levels) can prevent low oxygen levels during rapid sequence intubation in the emergency department. The monitor assesses patients' oxygen levels before the procedure, potentially aiding doctors in making safer decisions. Suitable participants for this trial include those with breathing issues, such as asthma or pneumonia, who are about to undergo intubation in the emergency room. As an unphased trial, this study allows patients to contribute to important research that could enhance emergency care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on patients who are at high risk of hypoxia during intubation, but it doesn't mention any requirements about existing medications.

What prior data suggests that the End-Tidal Oxygen Monitor is safe for use in the emergency department?

Research has shown that end-tidal oxygen (ETO2) monitors check oxygen delivery before inserting a breathing tube. Although specific safety data for ETO2 monitors is lacking, similar devices are generally considered safe.

Studies have found ETO2 monitoring useful in operating rooms, indicating it is a well-accepted tool. No major safety issues have been reported with its use in these settings. Anesthesiologists use this monitoring to ensure patients receive enough oxygen before inserting a breathing tube.

Overall, despite the absence of specific safety data for ETO2 monitors, their use in other medical settings suggests they are likely safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

End-Tidal Oxygen Monitoring (ETO2) is unique because it offers real-time monitoring to optimize preoxygenation during rapid sequence intubation (RSI), potentially reducing the risk of hypoxia. Unlike standard practices that rely on fixed oxygen flow rates and clinician judgment, ETO2 allows doctors to adjust their techniques based on actual oxygen saturation levels. Researchers are excited about this trial because it could lead to personalized, more effective preoxygenation strategies, ultimately improving patient safety and outcomes during emergency intubations.

What evidence suggests that the End-Tidal Oxygen Monitor is effective for preventing hypoxia during intubation?

Research shows that using an End-Tidal Oxygen (ETO2) monitor can enhance the process of oxygenating the lungs before inserting a breathing tube. In this trial, participants during the study period will use ETO2 monitoring to guide preoxygenation, while those in the control period will not. Studies have found that ETO2 levels above 85% indicate sufficient lung oxygenation, reducing the risk of hypoxia, a condition where the body lacks adequate oxygen. In emergencies like breathing tube insertion, knowing oxygen levels helps doctors make quick, effective decisions. ETO2 monitoring, commonly used in operating rooms, is now being tested in emergency departments. This method aims to make the procedure safer by reducing the chances of low oxygen levels. ^{1 2 3 4 6}

Who Is on the Research Team?

Matthew Oliver, MBBS

Principal Investigator

Sydney Local Health District

Nick Caputo, Md

Principal Investigator

Lincoln Medical Center

Are You a Good Fit for This Trial?

This trial is for patients in the emergency department who are critically ill and need a breathing tube inserted (intubation) due to respiratory problems like not getting enough oxygen. Specific eligibility criteria details were not provided.

Inclusion Criteria

I have a condition like obesity, lung disease, or injury that could lead to low oxygen levels.

The patient is deemed to be at a high risk of hypoxia during RSI as per the treating ED clinician, as defined by:

The patient is located in the ED resuscitation bay of the participating centre

Exclusion Criteria

The patient has a supraglottic device in-situ e.g iGel or LMA

I am under 18 years old.

I need a breathing tube immediately due to a heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Clinicians will not have access to ETO2 monitoring and routine RSI practices will be documented.

Duration not specified

Study Period

Use of ETO2 to guide preoxygenation with clinicians aiming for ETO2 >85%.

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• End-Tidal Oxygen Monitor

Trial Overview The study tests if using an end-tidal oxygen monitor, which measures how well lungs are being filled with oxygen before intubation, can reduce the risk of hypoxia during this procedure in the emergency setting.

How Is the Trial Designed?

Group I: Study period Experimental Treatment 1 Intervention

For all patients involved in the study, the only intervention will be the use of ETO2 to guide preoxygenation. All aspects of RSI will be at the discretion of the treating clinician including sedative/paralytic medications, positioning of the patient, preoxygenation method, intubation techniques and post-intubation sedation. Clinicians will be encouraged to aim for the highest ETO2 result possible with a goal of \>85%. Clinicians will be able to view the ETO2 values and can decide on any changes to the preoxygenation techniques if deemed necessary. These techniques may include improved patient positioning, improved face mask seal, increased oxygen flow, length of preoxygenation time, or altering the preoxygenation device.

Group II: Control period Active Control 1 Intervention

The control period includes a period whereby clinicians will not have access to ETO2 monitoring and routine RSI practices will be documented including all study variables. At all institutions, RSI is performed in a similar manner, utilising an airway checklist. There is no 'standard operating procedure' for RSI in any of the EDs and methods, therefore, vary depending on clinician preference and the condition of the patient, however, each site is a tertiary-level, university teaching hospital and therefore clinical practice is up to date and evidence-based. Standard preoxygenation methods in the Emergency department often consist of a bag-valve mask, with or without a PEEP valve, set at 15L/min, or the use of non-invasive ventilation or a non-rebreather mask, with or without a nasal cannula, set at 15 L/min or flush rate oxygen (\>40 L/min). US sites have access to high-flow (\>30L/min) oxygen. This is the only difference in the preoxygenation method.

End-Tidal Oxygen Monitor is already approved in United States, European Union for the following indications:

Approved in United States as End-Tidal Oxygen Monitor for:

• Assessment of preoxygenation during rapid sequence intubation in emergency departments

Approved in European Union as End-Tidal Oxygen Monitor for:

• Assessment of preoxygenation during rapid sequence intubation in emergency departments

Who Is Running the Clinical Trial?

Sydney Local Health District

Lead Sponsor

Trials

8

Recruited

2,100+

Published Research Related to This Trial

End-tidal CO2 (ETCO2) monitoring is already a standard practice during procedures like intubations and sedations in pediatric emergency departments, but it may not be utilized as frequently as it should be.

Understanding the principles of capnography and its relevance to ventilation and cardiac output is crucial for effectively implementing ETCO2 monitoring in various clinical situations within the pediatric emergency setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Update on End-Tidal CO2 Monitoring. Selby, ST., Abramo, T., Hobart-Porter, N.[2019]

End-tidal carbon dioxide (ETCO2) monitoring is a valuable noninvasive method for continuously assessing ventilation in critically ill infants and children.

Understanding the physiological principles and technological aspects of ETCO2 monitoring is essential for its effective clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-tidal CO2 monitoring in critically ill infants and children. Curley, MA., Thompson, JE.[2013]

In a study of 44 infants intubated in the delivery room, the colorimetric CO2 detector (Pedi-Cap®) correctly identified endotracheal tube placement in only 60% of cases, while it failed to change color in 31% of instances despite correct placement as confirmed by flow sensor recordings.

This suggests that relying solely on colorimetric CO2 detectors for verifying endotracheal tube placement in very preterm infants can be misleading, highlighting the need for additional verification methods to ensure accurate intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of flow waves and colorimetric CO2 detector for endotracheal tube placement during neonatal resuscitation. Schmölzer, GM., Poulton, DA., Dawson, JA., et al.[2013]

End tidal carbon dioxide (ETCO2) monitoring is a crucial non-invasive method for measuring exhaled CO2, recommended by the Intensive Care Society and the American Heart Association for confirming intubation and monitoring patients during transport.

ETCO2 monitoring is particularly effective for verifying endotracheal tube placement in prehospital settings, with modern devices being compact, durable, and easy to use, making them essential for advanced airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End tidal carbon dioxide monitoring in prehospital and retrieval medicine: a review. Donald, MJ., Paterson, B.[2022]

The use of unblinded end-tidal oxygen (ETO2) monitoring during rapid sequence intubation in emergency departments significantly improved preoxygenation, with median ETO2 levels rising from 80% in the control group to 90% in the study group (P < 0.001).

Clinicians adapted their techniques based on ETO2 feedback, with notable changes including a shift from non-rebreather masks to bag-valve-masks in 87% of cases and improved mask sealing in 54% of instances, indicating that ETO2 monitoring can lead to more effective preoxygenation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency physician use of end-tidal oxygen monitoring for rapidsequence intubation. Oliver, M., Caputo, ND., West, JR., et al.[2022]

The Early Warning Score O2 (EWS.O2) was developed to improve early detection of poor outcomes in patients with dyspnea by incorporating key respiratory parameters, showing better predictive accuracy than traditional scores like NEWS and NEWS2 in a study of 1729 emergency department patients.

With an Area Under the Receiver Operating Characteristic curve (AUROC) of 0.704, the EWS.O2 demonstrated superior performance in predicting critical outcomes such as ICU admission and death, suggesting it could enhance patient monitoring and treatment in respiratory distress situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new respiratory monitoring tool "Early Warning ScoreO2" for patients admitted at the emergency department with dyspnea. Viglino, D., L'her, E., Maltais, F., et al.[2021]

The study found that incorporating end-tidal CO2 (EtCO2) into Modified Early Warning Scores (MEWS) for monitoring post-operative patients is feasible and can help identify physiological derangements, although it also resulted in a high rate of false alarms (70% for concerning vital signs).

No adverse events were reported during the monitoring of 133 patients, suggesting that the automated MEWS system, including EtCO2, is safe for use in a general care hospital setting, particularly for patients with specific risk factors like obstructive sleep apnea and type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a novel postoperative monitoring system using automated Modified Early Warning Scores (MEWS) incorporating end-tidal capnography. Blankush, JM., Freeman, R., McIlvaine, J., et al.[2018]

A quality improvement project in two neonatal intensive care units successfully reduced nonactionable oximeter alarms by 78%, from an average of 9 to 2 alarms per patient per hour, without increasing the time infants spent in hypoxemia (SpO2 ≤ 80%) or hyperoxemia (SpO2 > 95%).

The reduction was achieved by adjusting alarm settings, including lowering the alarm limits, increasing alarm delays, and creating age-specific alarm profiles, demonstrating that thoughtful modifications can enhance patient monitoring without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Alarm Fatigue in Two Neonatal Intensive Care Units through a Quality Improvement Collaboration. Johnson, KR., Hagadorn, JI., Sink, DW.[2019]

The EMMA mainstream capnometer was validated for use in hyperbaric environments up to 281 kPa, demonstrating a significant linear relationship between expected and measured CO₂ levels, which is crucial for monitoring intubated patients.

While the EMMA capnometer showed an overestimation of CO₂ at pressures above 141 kPa, it still provides clinically useful data for monitoring expired CO₂ during hyperbaric oxygen treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical validation of the EMMA capnometer under hyperbaric conditions. Tucker, A., Smart, D.[2023]

The transcutaneous oxygen sensor effectively detected hypoxemia in patients during fiberoptic bronchoscopy, showing a strong correlation with arterial oxygen levels (PaO2).

This noninvasive sensor accurately identified all cases of PaO2 dropping below 65 mm Hg without causing any adverse effects, highlighting its safety and efficacy for monitoring oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous oxygen monitoring during fiberoptic bronchoscopy. Ghows, MB., Rosen, MJ., Chuang, MT., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7593475/

Emergency physician use of end‐tidal oxygen monitoring ... The purpose of this investigation is to determine whether the unblinded use of ETO 2 monitoring led to improvements in preoxygenation during rapid sequence ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05409573

Feasibility of End-tidal Oxygen Concentration Monitoring ... Monitoring the end-tidal of oxygen is recommended in operating room (OR). End-tidal of oxygen (EtO2) >90% is an indication of a correct preoxygenation. This ...

3. clinicalview.gehealthcare.com clinicalview.gehealthcare.com/white-paper/clinical-research-applications-end-tidal-oxygen-measurement

End-Tidal Oxygen Measurement White Paper Dr. Robert Bilkovski discusses the clinical research applications for end-tidal oxygen measurement in this white paper.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064419300654

Use of End Tidal Oxygen Monitoring to Assess ... The purpose of this study is to describe the use of end tidal oxygen (eto 2 ) during rapid sequence intubation in the emergency department.

5. withpower.com withpower.com/trial/phase-emergencies-7-2024-e8a1c

End-Tidal Oxygen Monitoring for Preventing Hypoxia Trial Overview The study tests if using an end-tidal oxygen monitor, which measures how well lungs are being filled with oxygen before intubation, can reduce ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2688115225000372

Assessment of Preoxygenation using Real-Time End-Tidal ... This study aimed to determine whether supplemental oxygen delivery would affect end-tidal oxygen measurements in healthy volunteers.