NCT06578468 End-Tidal Oxygen for Intubation in the Emergency Department
| NCT ID | NCT06578468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sydney Local Health District |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,400 participants in total. It began in 2024-08-05 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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: * 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: 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.
Contact & Investigator
Matthew Oliver, MBBS
STUDY CHAIR
Sydney Local Health District
Frequently Asked Questions
Who can join the NCT06578468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06578468 currently recruiting?
Yes, NCT06578468 is actively recruiting participants. Contact the research team at matthew.oliver@health.nsw.gov.au for enrollment information.
Where is the NCT06578468 trial being conducted?
This trial is being conducted at Minneapolis, United States, Albuquerque, United States, The Bronx, United States, Sydney, Australia and 5 additional locations.
Who is sponsoring the NCT06578468 clinical trial?
NCT06578468 is sponsored by Sydney Local Health District. The principal investigator is Matthew Oliver, MBBS at Sydney Local Health District. The trial plans to enroll 1,400 participants.