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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Hennepin Medical Center
NOT_YET_RECRUITING
Minneapolis
New Mexico
University of New Mexico Medical Center
NOT_YET_RECRUITING
Albuquerque
New York
Lincoln Medical Center
RECRUITING
The Bronx
Other Locations
Australia
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Liverpool Hospital
NOT_YET_RECRUITING
Sydney
Northern Beaches Hospital
RECRUITING
Sydney
Royal North Shore Hospital
NOT_YET_RECRUITING
Sydney
Royal Prince Alfred Hospital
RECRUITING
Sydney
Westmead Hospital
NOT_YET_RECRUITING
Sydney
Contact Information
Primary
Matthew Oliver, MBBS
matthew.oliver@health.nsw.gov.au
+61410188680
Backup
Naomi Derrick
naomi.derrick@health.nsw.gov.au
+61457240478
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1400
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sydney Local Health District

This content was sourced from clinicaltrials.gov