End-Tidal Oxygen for Intubation in the Emergency Department

NCT06578468 | Recruiting FDA Device

• 1 other identifier: 24-008
• Study Type: interventional
• Target: 1,400
• Locations: 2 countries
• Sites: 9

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.

Conditions

Critical Illness; Hypoxia; Respiratory Failure

Keywords

Emergency Intubation

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia

  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

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

Secondary Outcomes (1)

• Lowest oxygen saturations

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

Other Outcomes (8)

• Time from preoxygenation to endotracheal intubation

  Preoxygenation start time to endotracheal intubation confirmation

• Incidence of severe oxygen desaturation (SpO2 <80%)

  Induction of sedative medications and 2 minutes post ETT confirmation

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

  Induction of sedative medications and 2 minutes post ETT confirmation

Study Arms (2)

Control period

NO INTERVENTION

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.

Study period

EXPERIMENTAL

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.

Device: End-tidal oxygen monitor

Interventions

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.

Study period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sydney Local Health District: lead

Study Sites (9)

Hennepin Medical Center

Minneapolis, Minnesota, 55451, United States

NOT YET RECRUITING

University of New Mexico Medical Center

Albuquerque, New Mexico, 87106, United States

NOT YET RECRUITING

Lincoln Medical Center

The Bronx, New York, 10451, United States

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2000, Australia

NOT YET RECRUITING

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

RECRUITING

Liverpool Hospital

Sydney, New South Wales, Australia

NOT YET RECRUITING

Northern Beaches Hospital

Sydney, New South Wales, Australia

RECRUITING

Royal North Shore Hospital

Sydney, New South Wales, Australia

NOT YET RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

NOT YET RECRUITING

Related Publications (13)

• 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.

  PMID: 21150574 BACKGROUND

• 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.

  PMID: 12359280 BACKGROUND

• 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.

  PMID: 28582801 BACKGROUND

• 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.

  PMID: 15590254 BACKGROUND

• 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.

  PMID: 15284540 BACKGROUND

• 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.

  PMID: 22050948 BACKGROUND

• 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.

  PMID: 26556848 BACKGROUND

• 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.

  PMID: 30879700 BACKGROUND

• 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.

  PMID: 33145509 BACKGROUND

• 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/.

  BACKGROUND

• 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.

  PMID: 32087011 BACKGROUND

• 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.

  PMID: 25662947 BACKGROUND

• 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.

  PMID: 29800096 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Hypoxia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Matthew Oliver, MBBS

  Sydney Local Health District

  STUDY CHAIR

• Nick Caputo, Md

  Lincoln Medical Center

  STUDY CHAIR

Central Study Contacts

Matthew Oliver, MBBS

CONTACT

+61410188680; matthew.oliver@health.nsw.gov.au

Naomi Derrick

CONTACT

+61457240478; naomi.derrick@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Specialist

Model Details: Stepped-wedge randomised control trial

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 29, 2024
• Study Start: August 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: No end date
• Access Criteria: a signed data access agreement research testing a hypothesis a protocol that has been approved by an institutional review board a proposal that has received approval from the principal investigator

Locations

AU (6); US (3)