Using end-tidal oxygen monitoring to improve intubation safety in emergency departments

Preoxygenation Using End-Tidal Oxygen for Rapid Sequence Intubation in the Emergency Department (The PREOXED Trial) - a Multicentre Stepped Wedge Cluster Randomised Control Trial

This study tests if using end-tidal oxygen monitoring during intubation can help keep patients from getting low oxygen levels in emergency departments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sydney Local Health District (Government)
• Locations: 9 sites (Minneapolis, Minnesota and 8 other locations)
• Trial ID: NCT06578468 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of end-tidal oxygen (ETO2) monitoring during rapid sequence intubation (RSI) in emergency departments. The study aims to determine if ETO2 can reduce the incidence of hypoxia during intubation by providing an objective measurement of preoxygenation efficacy. Patients at high risk of hypoxia will be monitored to assess the impact of ETO2 on their outcomes during the intubation process. The trial is conducted in multiple emergency departments to gather diverse data on its effectiveness.

Who should consider this trial

Good fit: Ideal candidates include patients in the emergency department who are at high risk of hypoxia during intubation, such as those requiring oxygen therapy or with respiratory pathologies.

Not a fit: Patients who are not undergoing intubation or those with stable respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of hypoxia and improve outcomes for patients undergoing intubation in emergency settings.

How similar studies have performed: Other studies have shown promising results with similar monitoring approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. The patient is located in the ED resuscitation bay of the participating centre.
2. The planned procedure is orotracheal intubation using a laryngoscope and RSI technique with preoxygenation for patients who are spontaneously breathing.
3. The patient is deemed to be at a high risk of hypoxia during RSI as per the treating ED clinician, as defined by:

   * Any patient requiring any form of oxygen therapy before preoxygenation.
   * Any patient with respiratory pathology based on clinical or radiological findings. Including, but not limited to:

     * Pneumonia, pulmonary oedema, acute respiratory distress syndrome (ARDS), aspiration, pulmonary contusion from trauma, infective exacerbations of known lung disease (e.g. asthma, pulmonary fibrosis, emphysema) or pulmonary embolism (PE)
   * Any patient with high oxygen consumption. Including, but not limited to:

     * Sepsis, Diabetic ketoacidosis, alcohol or drug withdrawal, seizures, thyrotoxicosis
   * Any underlying patient condition that may predispose to hypoxemia. Including, but not limited to:

     * Obesity, pregnancy, underlying lung disease (e.g. asthma, pulmonary fibrosis, emphysema), severe injury- hypovolaemia/haemorrhage.
   * or any other patient that the treating clinician has a high concern for hypoxemia during RSI.

Exclusion Criteria:

1. Patient is known to be less than 18 years old.
2. The patient has a supraglottic device in-situ e.g iGel or LMA.
3. The patient is known to be pregnant.
4. The patient is known to be a prisoner.
5. The patient was intubated in the prehospital environment.
6. Immediate need for tracheal intubation precludes preoxygenation i.e. the patient is in cardiac arrest.

Where this trial is running

Minneapolis, Minnesota and 8 other locations

• Hennepin Medical Center — Minneapolis, Minnesota, United States (Not_yet_recruiting)
• University of New Mexico Medical Center — Albuquerque, New Mexico, United States (Not_yet_recruiting)
• Lincoln Medical Center — The Bronx, New York, United States (Recruiting)
• Westmead Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Recruiting)
• Liverpool Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Northern Beaches Hospital — Sydney, New South Wales, Australia (Recruiting)
• Royal North Shore Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Matthew Oliver, MBBS

Conditions Critical Illness; Hypoxia; Respiratory Failure; Emergency Intubation