End-Tidal Oxygen Monitoring for Preventing Hypoxia

(PREOXED Trial)

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy. This is currently not available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.

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 data supports the effectiveness of the End-Tidal Oxygen Monitor treatment?

While there is no direct research on the End-Tidal Oxygen Monitor, similar monitoring tools like the End-Tidal CO2 (ETCO2) monitor have been shown to effectively assess ventilation in critically ill patients, suggesting that monitoring end-tidal gases can be beneficial in clinical settings. ^{1 2 3 4 5}

Is end-tidal oxygen monitoring safe for humans?

There is no specific safety data available for end-tidal oxygen monitoring, but similar monitoring systems like end-tidal CO2 have been used safely in various medical settings without reported adverse events. ^{1 2 6 7 8}

How is the End-Tidal Oxygen Monitor treatment different from other treatments for preventing hypoxia?

The End-Tidal Oxygen Monitor is unique because it continuously measures the oxygen levels in the breath you exhale, helping to prevent low oxygen levels (hypoxia) without being invasive. This is different from other methods that might require blood samples or more invasive procedures to monitor oxygen levels. ^{1 2 4 9 10}

Research Team

Nick Caputo, Md

Principal Investigator

Lincoln Medical Center

Matthew Oliver, MBBS

Principal Investigator

Sydney Local Health District

Eligibility Criteria

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

I am under 18 years old.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

End-tidal CO2 monitoring in critically ill infants and children. [2013]

2. Ireland pubmed.ncbi.nlm.nih.gov

Assessment of flow waves and colorimetric CO2 detector for endotracheal tube placement during neonatal resuscitation. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing Alarm Fatigue in Two Neonatal Intensive Care Units through a Quality Improvement Collaboration. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

Technical validation of the EMMA capnometer under hyperbaric conditions. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a new respiratory monitoring tool "Early Warning ScoreO2" for patients admitted at the emergency department with dyspnea. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Emergency physician use of end-tidal oxygen monitoring for rapidsequence intubation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An Update on End-Tidal CO2 Monitoring. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of a novel postoperative monitoring system using automated Modified Early Warning Scores (MEWS) incorporating end-tidal capnography. [2018]

9. England pubmed.ncbi.nlm.nih.gov

End tidal carbon dioxide monitoring in prehospital and retrieval medicine: a review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous oxygen monitoring during fiberoptic bronchoscopy. [2019]