RecruitingNot ApplicableNCT06578468

End-Tidal Oxygen for Intubation in the Emergency Department

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

Sponsor

Sydney Local Health District

Enrollment

1,400 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

Respiratory Failure Hypoxia Critical Illness

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

The patient is located in the ED resuscitation bay of the participating centre.
The planned procedure is orotracheal intubation using a laryngoscope and RSI technique with preoxygenation for patients who are spontaneously breathing.
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 Criteria6

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

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Interventions

DEVICEEnd-tidal oxygen monitor

The only additional equipment required for this study is the Philips™ IntelliVue G7m Gas Analyser Module 866173. This provides a non-dispersive infrared measurement of respiratory gases and a paramagnetic measurement of oxygen. At Lincoln Medical Center, the gas analyser used will be a Philips G5 gas analyser connected to a Philips Intellivue MP 70. At the University of New Mexico Medical Center, the Masimo root monitor is used. The gas analysers produce display waves for O2 and CO2, together with numerics for end-tidal values for O2 and CO2 and to our knowledge, there are no differences in values between the various devices used. The gas sampling occurs through a side-stream sampling tube at a rate of 200ml/min ±20 ml/min, which is either obtained from a nasal cannula in the spontaneously breathing patient or a sidestream line if connected to a BVM.