1400 Participants Needed

End-Tidal Oxygen Monitoring for Preventing Hypoxia

(PREOXED Trial)

Recruiting at 8 trial locations
MO
ND
Overseen ByNaomi Derrick
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sydney Local Health District
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.127910

Who Is on the Research Team?

NC

Nick Caputo, Md

Principal Investigator

Lincoln Medical Center

MO

Matthew Oliver, MBBS

Principal Investigator

Sydney Local Health District

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
See 4 more

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.
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Study periodExperimental Treatment1 Intervention
Group II: Control periodActive Control1 Intervention

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

Find a Clinic Near You

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

Citations

End-tidal CO2 monitoring in critically ill infants and children. [2013]
Assessment of flow waves and colorimetric CO2 detector for endotracheal tube placement during neonatal resuscitation. [2013]
Reducing Alarm Fatigue in Two Neonatal Intensive Care Units through a Quality Improvement Collaboration. [2019]
Technical validation of the EMMA capnometer under hyperbaric conditions. [2023]
Evaluation of a new respiratory monitoring tool "Early Warning ScoreO2" for patients admitted at the emergency department with dyspnea. [2021]
Emergency physician use of end-tidal oxygen monitoring for rapidsequence intubation. [2022]
An Update on End-Tidal CO2 Monitoring. [2019]
Implementation of a novel postoperative monitoring system using automated Modified Early Warning Scores (MEWS) incorporating end-tidal capnography. [2018]
End tidal carbon dioxide monitoring in prehospital and retrieval medicine: a review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Transcutaneous oxygen monitoring during fiberoptic bronchoscopy. [2019]
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