End-Tidal Oxygen for Intubation in the Emergency Department
NCT Number: NCT06578468
Acronym: PREOXED
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Illness|Hypoxia|Respiratory Failure
Interventions: DEVICE: End-tidal oxygen monitor
Sponsor: Sydney Local Health District
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1400
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-05
Completion Date: 2025-12-31
Locations: Hennepin Medical Center, Minneapolis, Minnesota, 55451, United States|University of New Mexico Medical Center, Albuquerque, New Mexico, 87106, United States|Lincoln Medical Center, Bronx, New York, 10451, United States|Westmead Hospital, Sydney, New South Wales, 2000, Australia|Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia|Liverpool Hospital, Sydney, New South Wales, Australia|Northern Beaches Hospital, Sydney, New South Wales, Australia|Royal North Shore Hospital, Sydney, New South Wales, Australia|The Alfred Hospital, Melbourne, Victoria, Australia

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.

Primary Outcome Measures: 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, The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography
Secondary Outcome Measures: Lowest oxygen saturations, The lowest oxygen saturation (SpO2) during the peri-intubation period, The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography
Other Outcome Measures: Time from preoxygenation to endotracheal intubation, Time from preoxygenation to endotracheal intubation, Preoxygenation start time to endotracheal intubation confirmation|Incidence of severe oxygen desaturation (SpO2 <80%), Incidence of severe oxygen desaturation (SpO2 \<80%), Induction of sedative medications and 2 minutes post ETT confirmation|Incidence of very severe oxygen desaturation (SpO2 <70%), Incidence of very severe oxygen desaturation (SpO2 \<70%), Induction of sedative medications and 2 minutes post ETT confirmation|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, During preoxygenation|Incidence of the number of patients with pre-oxygenation technique changes to achieve higher ETO2 in intervention arm, Incidence in pre-oxygenation changes in technique to deliver higher ETO2:

* Improved mask seal
* Increased O2 flow rate
* Increased Preoxygenation time, During preoxygenation|Number of re-oxygenation events, A re-oxygenation attempt is a failed first attempt at ETT placement followed by administration of an oxygen delivery device (BVM, NIV, supraglottic device) to maintain SpO2 levels, During preoxygenation|Cardiovascular complications during RSI, * Bradycardia (HR\< 40 bpm)
* Tachycardia (HR\> 120 bpm)
* Hypotension (SBP\< 90 mm Hg or a 30mmHg reduction from baseline), Induction of sedative medications and 2 minutes post ETT confirmation|Other complications during RSI, Operator reported aspiration between induction and intubation Oesophageal intubation recognised after the laryngoscope blade has been removed, detected by waveform ETCO2 Cardiac arrest occurred during RSI, Induction of sedative medications and 2 minutes post ETT confirmation