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Behavioural Intervention

End-Tidal Oxygen Monitoring for Preventing Hypoxia (PREOXED Trial)

N/A
Recruiting
Research Sponsored by Sydney Local Health District
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient requiring any form of oxygen therapy before preoxygenation
Any patient with respiratory pathology based on clinical or radiological findings including pneumonia, pulmonary oedema, ARDS, aspiration, pulmonary contusion from trauma, infective exacerbations of known lung disease (e.g. asthma, pulmonary fibrosis, emphysema) or pulmonary embolism (PE)
Must not have
Patient is known to be less than 18 years old
Immediate need for tracheal intubation precludes preoxygenation i.e. the patient is in cardiac arrest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up induction of sedative medications and 2 minutes post ett confirmation
Awards & highlights

Summary

"This trial evaluates whether using end-tidal oxygen levels can help prevent low oxygen levels during intubation in the emergency department. It is a high-risk procedure where patients are given extra oxygen before intub

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves monitoring technology rather than a drug or medical intervention, there are no direct side effects from the device itself. However, risks may be associated with the intubation process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need oxygen therapy before undergoing preoxygenation.
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I have a lung condition like pneumonia, asthma, or a blood clot in my lungs.
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I have a condition that increases my oxygen use, like sepsis or seizures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I need a breathing tube immediately due to a heart attack.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ett] is confirmed on waveform capnography
This trial's timeline: 3 weeks for screening, Varies for treatment, and the time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ett] is confirmed on waveform capnography for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of hypoxia
Secondary study objectives
Lowest oxygen saturations
Other study objectives
Cardiovascular complications during RSI
Incidence of severe oxygen desaturation (SpO2 <80%)
Incidence of the number of patients with pre-oxygenation method changes to achieve higher ETO2 in intervention arm
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study periodExperimental Treatment1 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 periodActive Control1 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.

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Who is running the clinical trial?

Sydney Local Health DistrictLead Sponsor
6 Previous Clinical Trials
644 Total Patients Enrolled
Nick Caputo, MdStudy ChairLincoln Medical Center
Matthew Oliver, MBBSStudy ChairSydney Local Health District
~933 spots leftby Dec 2025
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