RECRUITING

End-Tidal Oxygen for Intubation in the Emergency Department

Conditions

Critical Illness Hypoxia Respiratory Failure Emergency Intubation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-08-05

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06578468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Matthew Oliver, MBBS

CONTACT

+61410188680

matthew.oliver@health.nsw.gov.au

Naomi Derrick

CONTACT

+61457240478

naomi.derrick@health.nsw.gov.au

Principal Investigator

Matthew Oliver, MBBS

STUDY_CHAIR

Sydney Local Health District

Nick Caputo, Md

STUDY_CHAIR

Lincoln Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sydney Local Health District

Matthew Oliver, MBBS, STUDY_CHAIR, Sydney Local Health District
Nick Caputo, Md, STUDY_CHAIR, Lincoln Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-05

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-08-05

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Emergency Intubation

Additional Relevant MeSH Terms

Critical Illness
Hypoxia
Respiratory Failure