None listed
Conditions
Brief 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 not currently available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.
Interventions
For all patients involved in the study, the only intervention will be the use of End-tidal oxygen (ETO2) to guide preoxygenation. All aspects of rapid sequence intubation (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. Preoxygenation without the use of ETO2 is generally performed for a minimum of 3 minutes, however, with the use of ETO2 this m
For all patients involved in the study, the only intervention will be the use of End-tidal oxygen (ETO2) to guide preoxygenation. All aspects of rapid sequence intubation (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. Preoxygenation without the use of ETO2 is generally performed for a minimum of 3 minutes, however, with the use of ETO2 this may be performed earlier than 3 minutes if the correct ETO2 level has been reached. 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. For hospitals in Sydney, 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. The IntelliVue G7m Gas Analyser Module is designed to work with the IntelliVue patient monitors currently used in the EDs at the Sydney sites. 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. Data collection and adherence to the intervention will be monitored by research staff if available Study design The trial will be an international, multicentre, stepped-wedge randomised control trial on the implementation of ETO2 use in EDs for patients requiring RSI. A cluster will compose an individual hospital site and each site will serve as its own control with an implementation phase conducted at each site until all sites are recruited into the study period. To account for the differences in ED presentation rates at the various sites the cluster blocks will consist of patient numbers rather than a defined period of time. However, nearly all the sites will be recruiting at a similar rate, given that each site intubates 20-30 patients per month. The trial will have 9 steps with 25 patients per step. Giving a total of 1400 patients (please see 'power calculation' in section 6.
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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: o 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: o Sepsis, Diabetic ketoacidosis, alcohol or drug withdrawal, seizures, thyrotoxicosis - Any underlying patient condition that may predispose to hypoxemia. Including, but not limited to: o 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.
Outcome results
None listed