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NCT Number: NCT06578468

End-Tidal Oxygen for Intubation in the Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Hospital, Sydney, New South Wales, Australia

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About this study

BACKGROUND AND INTRODUCTION

Rapid Sequence Intubation (RSI) is a common procedure in Emergency Departments (ED). However, it is a high-risk procedure and is associated with significant complications including hypoxia, failed intubation, hypotension, trauma and aspiration. (1-3) Specifically, hypoxia during intubation can lead to poor outcomes such as dysrhythmias, haemodynamic compromise, hypoxic brain injury and death and therefore oxygen desaturation is of primary concern during any intubation procedure. (4, 5) In order to prevent desaturation events during intubation, a number of steps are taken by clinicians. These include optimal patient positioning, adequate preoxygenation, assessment of airway anatomy and development of a detailed airway plan as well as the use of apnoeic oxygenation.(6)

Effective preoxygenation is vital to ensure that the patient does not develop hypoxia during the period between induction (administration of sedative and paralytic agents) and restoration of ventilation by successful endotracheal intubation or rescue breathing. Various methods of preoxygenation have been developed to wash the nitrogen out of the lungs (denitrogenation) which allows the functional residual capacity (FRC) to act as an oxygen reservoir during intubation, which prolongs safe apnoea time, therefore, preventing desaturation whilst an endotracheal tube (ETT) is placed.

Adequate preoxygenation is especially important for those patients at highest risk of hypoxia during the RSI. This patient group includes those with underlying lung pathology e.g. pneumonia, patients with increased metabolic demand e.g. sepsis, patients with an oxygen requirement prior to RSI, or patients with underlying conditions that predisposes to hypoxia e.g. obesity.

For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation. ETO2 measures the exhaled oxygen concentration and is a marker of the oxygen concentration in the alveoli. Prior to induction, anaesthetists most commonly preoxygenate with a face-mask seal via either a circle circuit, Mapleson circuit, or bag valve mask. ETO2 provides an objective measurement of preoxygenation efficacy. The Difficult Airway Society guidelines suggest aiming for an ETO2 of ≥87% prior to commencing RSI.(7) ETO2 levels are not routinely measured in Emergency Departments.

Currently, it is not possible to measure the effectiveness of preoxygenation in the ED. Pulse-wave oximetry reflects peripheral oxygen saturation and not the pulmonary oxygen concentration. Therefore, to attempt to optimize preoxygenation the emergency clinician currently can only use time as a surrogate. The typically recommended duration of preoxygenation is > 3 minutes.

Recently, the investigators conducted two multi-site studies (Ethics identifier: 2019/ETH06644) that investigated the use of ETO2 in the ED.(8, 9) The first study was conducted with clinicians blinded to the ETO2 result (8). The investigators demonstrated that preoxygenation was uniformly poor with only 26% of patients achieving the required target ETO2 of ≥85%. The investigators then completed a second study where clinicians had access to ETO2 values and found that the proportion of patients reaching levels ≥85% was improved to 67% of patients. (9) The prevalence of hypoxemia (SpO2 <90%) in the group blinded to ETO2 was 18% (n=18, 95% CI: 11% to 27%) and was 8% in the group where ETO2 was available (n = 8, 95% CI: 4% to 15%). These studies indicate that the use of ETO2 may substantially improve preoxygenation in the ED and therefore reduce the risk of hypoxia.

These studies, however, were focused on preoxygenation practices and not patient-oriented outcomes (hypoxia) and were limited in design and resources. Consequently, it is still unclear whether the use of ETO2 in the ED leads to improved clinical outcomes.

RATIONALE FOR PERFORMING THE STUDY

The aim of this study is to determine the effectiveness of ETO2 monitoring in preventing desaturation for patients with a high risk of hypoxia undergoing RSI in ED.

HYPOTHESIS

The investigators hypothesise that the use of ETO2 monitoring leads to reduced rates of oxygen desaturation during the peri-intubation period compared to when it is not used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.
  • The patient was intubated in the prehospital environment.
  • Immediate need for tracheal intubation precludes preoxygenation i.e. the patient is in cardiac arrest.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Lowest oxygen saturations

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

    The lowest oxygen saturation (SpO2) during the peri-intubation period

Other outcomes

  1. Time from preoxygenation to endotracheal intubation

    Time frame: Preoxygenation start time to endotracheal intubation confirmation

    Time from preoxygenation to endotracheal intubation

  2. Incidence of severe oxygen desaturation (SpO2 <80%)

    Time frame: Induction of sedative medications and 2 minutes post ETT confirmation

    Incidence of severe oxygen desaturation (SpO2 <80%)

  3. Incidence of very severe oxygen desaturation (SpO2 <70%)

    Time frame: Induction of sedative medications and 2 minutes post ETT confirmation

    Incidence of very severe oxygen desaturation (SpO2 <70%)

  4. Incidence of the number of patients with pre-oxygenation method changes to achieve higher ETO2 in intervention arm

    Time frame: During preoxygenation

    Incidence in pre-oxygenation changes in method to deliver higher ETO2:

    • BVM
    • BVM+PEEP
    • HFNP
    • NIV
  5. Incidence of the number of patients with pre-oxygenation technique changes to achieve higher ETO2 in intervention arm

    Time frame: During preoxygenation

    Incidence in pre-oxygenation changes in technique to deliver higher ETO2:

    • Improved mask seal
    • Increased O2 flow rate
    • Increased Preoxygenation time
  6. Number of re-oxygenation events

    Time frame: During preoxygenation

    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

  7. Cardiovascular complications during RSI

    Time frame: Induction of sedative medications and 2 minutes post ETT confirmation

    • Bradycardia (HR< 40 bpm)
    • Tachycardia (HR> 120 bpm)
    • Hypotension (SBP< 90 mm Hg or a 30mmHg reduction from baseline)
  8. Other complications during RSI

    Time frame: Induction of sedative medications and 2 minutes post ETT confirmation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Oliver, MBBS

CONTACT

[email protected]

+61410188680

Naomi Derrick

CONTACT

[email protected]

+61457240478

Sponsors and collaborators

Lead sponsor

Sydney Local Health District

Other Gov

Registry information

Official study title

Preoxygenation Using End-Tidal Oxygen for Rapid Sequence Intubation in the Emergency Department (The PREOXED Trial) - a Multicentre Stepped Wedge Cluster Randomised Control Trial

Acronym: PREOXED

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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