End-Tidal Oxygen for Intubation in the Emergency Department
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSydney Local Health District
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Any patient requiring any form of oxygen therapy before preoxygenation.
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)
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
End-tidal oxygen monitor
DeviceThe 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.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Control periodNo intervention 0 interventions
Group B: Study periodExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of hypoxia
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
Time frame
The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnographySecondary outcomes
1
Lowest oxygen saturations
The lowest oxygen saturation (SpO2) during the peri-intubation period
Time frame
The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnographyOther outcomes
1
Time from preoxygenation to endotracheal intubation
Time from preoxygenation to endotracheal intubation
Time frame
Preoxygenation start time to endotracheal intubation confirmation2
Incidence of severe oxygen desaturation (SpO2 <80%)
Incidence of severe oxygen desaturation (SpO2 \<80%)
Time frame
Induction of sedative medications and 2 minutes post ETT confirmation3
Incidence of very severe oxygen desaturation (SpO2 <70%)
Incidence of very severe oxygen desaturation (SpO2 \<70%)
Time frame
Induction of sedative medications and 2 minutes post ETT confirmation4
Incidence of the number of patients with pre-oxygenation method changes to achieve higher ETO2 in intervention arm
Incidence in pre-oxygenation changes in method to deliver higher ETO2: * BVM * BVM+PEEP * HFNP * NIV
Time frame
During preoxygenationSponsors and contacts
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Source ClinicalTrials.gov