End-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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of hypoxia — The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography The proportion of patients that experience oxygenation desaturation (SpO2 \<93%, or \>10% from baseline if SpO2 \<93% at the end of preoxygenation) during the peri-intubation period
Trial sites (9)
Facility
City
Region
Status
Hennepin Medical Center
Minneapolis
Minnesota
Not Yet Recruiting
University of New Mexico Medical Center
Albuquerque
New Mexico
Not Yet Recruiting
Lincoln Medical Center
The Bronx
New York
Recruiting
Westmead Hospital
Sydney
New South Wales
Not Yet Recruiting
Royal Prince Alfred Hospital
Sydney
New South Wales
Recruiting
Liverpool Hospital
Sydney
New South Wales
Not Yet Recruiting
Northern Beaches Hospital
Sydney
New South Wales
Recruiting
Royal North Shore Hospital
Sydney
New South Wales
Not Yet Recruiting
The Alfred Hospital
Melbourne
Victoria
Not Yet Recruiting
More Sydney Local Health District trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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