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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06578468




Registration number
NCT06578468
Ethics application status
Date submitted
21/08/2024
Date registered
29/08/2024
Date last updated
19/09/2024

Titles & IDs
Public title
End-Tidal Oxygen for Intubation in the Emergency Department
Scientific 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
Secondary ID [1] 0 0
24-008
Universal Trial Number (UTN)
Trial acronym
PREOXED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Hypoxia 0 0
Respiratory Failure 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - End-tidal oxygen monitor

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.


Treatment: Devices: End-tidal oxygen monitor
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of hypoxia
Timepoint [1] 0 0
The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography
Secondary outcome [1] 0 0
Lowest oxygen saturations
Timepoint [1] 0 0
The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [4] 0 0
Northern Beaches Hospital - Sydney
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
United States of America
State/province [2] 0 0
New Mexico
Country [3] 0 0
United States of America
State/province [3] 0 0
New York

Funding & Sponsors
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06578468
Trial related presentations / publications
Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.
Bair AE, Filbin MR, Kulkarni RG, Walls RM. The failed intubation attempt in the emergency department: analysis of prevalence, rescue techniques, and personnel. J Emerg Med. 2002 Aug;23(2):131-40. doi: 10.1016/s0736-4679(02)00501-2. Erratum In: J Emerg Med 2002 Oct;23(3):325.
Alkhouri H, Vassiliadis J, Murray M, Mackenzie J, Tzannes A, McCarthy S, Fogg T. Emergency airway management in Australian and New Zealand emergency departments: A multicentre descriptive study of 3710 emergency intubations. Emerg Med Australas. 2017 Oct;29(5):499-508. doi: 10.1111/1742-6723.12815. Epub 2017 Jun 5.
Mort TC. The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location. J Clin Anesth. 2004 Nov;16(7):508-16. doi: 10.1016/j.jclinane.2004.01.007.
Davis DP, Dunford JV, Poste JC, Ochs M, Holbrook T, Fortlage D, Size MJ, Kennedy F, Hoyt DB. The impact of hypoxia and hyperventilation on outcome after paramedic rapid sequence intubation of severely head-injured patients. J Trauma. 2004 Jul;57(1):1-8; discussion 8-10. doi: 10.1097/01.ta.0000135503.71684.c8.
Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
Caputo ND, Oliver M, West JR, Hackett R, Sakles JC. Use of End Tidal Oxygen Monitoring to Assess Preoxygenation During Rapid Sequence Intubation in the Emergency Department. Ann Emerg Med. 2019 Sep;74(3):410-415. doi: 10.1016/j.annemergmed.2019.01.038. Epub 2019 Mar 14.
Oliver M, Caputo ND, West JR, Hackett R, Sakles JC. Emergency physician use of end-tidal oxygen monitoring for rapidsequence intubation. J Am Coll Emerg Physicians Open. 2020 Sep 28;1(5):706-713. doi: 10.1002/emp2.12260. eCollection 2020 Oct.
American College of Emergency Physicians (ACEP) Policy statement: Rapid-Sequence Intubation February 2018 [Available from: https://www.acep.org/patient-care/policy-statements/rapid-sequence-intubation/.
Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020 Jun 1;49(3):979-995. doi: 10.1093/ije/dyz237.
Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
Public notes

Contacts
Principal investigator
Name 0 0
Matthew Oliver, MBBS
Address 0 0
Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthew Oliver, MBBS
Address 0 0
Country 0 0
Phone 0 0
+61410188680
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06578468