End-Tidal Oxygen for Intubation in the Emergency Department

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Sydney Local Health District
Study ID
NCT06578468
Status
Recruiting
Apply to this trial

Conditions

  • Critical Illness
  • Hypoxia
  • Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • End-tidal oxygen monitor — DEVICE
    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 Details

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.

Key Dates

Start date
Aug 5, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
1,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • No Intervention: Control period
    The control period includes a period whereby clinicians will not have access to ETO2 monitoring and routine RSI practices will be documented including all study variables. At all institutions, RSI is performed in a similar manner, utilising an airway checklist. There is no 'standard operating procedure' for RSI in any of the EDs and methods, therefore, vary depending on clinician preference and the condition of the patient, however, each site is a tertiary-level, university teaching hospital and therefore clinical practice is up to date and evidence-based. Standard preoxygenation methods in the Emergency department often consist of a bag-valve mask, with or without a PEEP valve, set at 15L/min, or the use of non-invasive ventilation or a non-rebreather mask, with or without a nasal cannula, set at 15 L/min or flush rate oxygen (\>40 L/min). US sites have access to high-flow (\>30L/min) oxygen. This is the only difference in the preoxygenation method.
  • Experimental: Study period
    For all patients involved in the study, the only intervention will be the use of ETO2 to guide preoxygenation. All aspects of 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. 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.

Primary Outcome Measure

Incidence of hypoxia [ Time Frame: The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Hennepin Medical CenterMinneapolisMinnesota55451
Brian Driver, MD
[email protected]
University of New Mexico Medical CenterAlbuquerqueNew Mexico87106
Darren Braude, MD
[email protected]
Lincoln Medical CenterThe BronxNew York10451
Nicholas Caputo, MD
[email protected]

Find similar trials in Minneapolis, MN

By research site
Hennepin Medical Center· Minneapolis, MNUniversity of New Mexico Medical Center· Albuquerque, NMLincoln Medical Center· The Bronx, NY

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