Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
Study NCT ID:
NCT06578468
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
End-Tidal Oxygen for Intubation in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Stepped-wedge randomised control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time from preoxygenation to endotracheal intubation', 'timeFrame': 'Preoxygenation start time to endotracheal intubation confirmation', 'description': 'Time from preoxygenation to endotracheal intubation'}, {'measure': 'Incidence of severe oxygen desaturation (SpO2 <80%)', 'timeFrame': 'Induction of sedative medications and 2 minutes post ETT confirmation', 'description': 'Incidence of severe oxygen desaturation (SpO2 \\<80%)'}, {'measure': 'Incidence of very severe oxygen desaturation (SpO2 <70%)', 'timeFrame': 'Induction of sedative medications and 2 minutes post ETT confirmation', 'description': 'Incidence of very severe oxygen desaturation (SpO2 \\<70%)'}, {'measure': 'Incidence of the number of patients with pre-oxygenation method changes to achieve higher ETO2 in intervention arm', 'timeFrame': 'During preoxygenation', 'description': 'Incidence in pre-oxygenation changes in method to deliver higher ETO2:\n\n* BVM\n* BVM+PEEP\n* HFNP\n* NIV'}, {'measure': 'Incidence of the number of patients with pre-oxygenation technique changes to achieve higher ETO2 in intervention arm', 'timeFrame': 'During preoxygenation', 'description': 'Incidence in pre-oxygenation changes in technique to deliver higher ETO2:\n\n* Improved mask seal\n* Increased O2 flow rate\n* Increased Preoxygenation time'}, {'measure': 'Number of re-oxygenation events', 'timeFrame': 'During preoxygenation', 'description': 'A re-oxygenation attempt is a failed first attempt at ETT placement followed by administration of an oxygen delivery device (BVM, NIV, supraglottic device) to maintain SpO2 levels'}, {'measure': 'Cardiovascular complications during RSI', 'timeFrame': 'Induction of sedative medications and 2 minutes post ETT confirmation', 'description': '* Bradycardia (HR\\< 40 bpm)\n* Tachycardia (HR\\> 120 bpm)\n* Hypotension (SBP\\< 90 mm Hg or a 30mmHg reduction from baseline)'}, {'measure': 'Other complications during RSI', 'timeFrame': 'Induction of sedative medications and 2 minutes post ETT confirmation', 'description': 'Operator reported aspiration between induction and intubation Oesophageal intubation recognised after the laryngoscope blade has been removed, detected by waveform ETCO2 Cardiac arrest occurred during RSI'}], 'primaryOutcomes': [{'measure': 'Incidence of hypoxia', 'timeFrame': 'The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Lowest oxygen saturations', 'timeFrame': 'The time when laryngoscope first enters the mouth to 2 minutes after the endotracheal tube [ETT] is confirmed on waveform capnography', 'description': 'The lowest oxygen saturation (SpO2) during the peri-intubation period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Emergency Intubation'], 'conditions': ['Critical Illness', 'Hypoxia', 'Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '21150574', 'type': 'BACKGROUND', 'citation': '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': '12359280', 'type': 'BACKGROUND', 'citation': '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': '28582801', 'type': 'BACKGROUND', 'citation': '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': '15590254', 'type': 'BACKGROUND', 'citation': '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': '15284540', 'type': 'BACKGROUND', 'citation': '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': '22050948', 'type': 'BACKGROUND', 'citation': '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': '26556848', 'type': 'BACKGROUND', 'citation': "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': '30879700', 'type': 'BACKGROUND', 'citation': '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': '33145509', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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/.'}, {'pmid': '32087011', 'type': 'BACKGROUND', 'citation': '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': '25662947', 'type': 'BACKGROUND', 'citation': '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': '29800096', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.', 'detailedDescription': 'BACKGROUND AND INTRODUCTION\n\nRapid Sequence Intubation (RSI) is a common procedure in Emergency Departments (ED). However, it is a high-risk procedure and is associated with significant complications including hypoxia, failed intubation, hypotension, trauma and aspiration. (1-3) Specifically, hypoxia during intubation can lead to poor outcomes such as dysrhythmias, haemodynamic compromise, hypoxic brain injury and death and therefore oxygen desaturation is of primary concern during any intubation procedure. (4, 5) In order to prevent desaturation events during intubation, a number of steps are taken by clinicians. These include optimal patient positioning, adequate preoxygenation, assessment of airway anatomy and development of a detailed airway plan as well as the use of apnoeic oxygenation.(6)\n\nEffective preoxygenation is vital to ensure that the patient does not develop hypoxia during the period between induction (administration of sedative and paralytic agents) and restoration of ventilation by successful endotracheal intubation or rescue breathing. Various methods of preoxygenation have been developed to wash the nitrogen out of the lungs (denitrogenation) which allows the functional residual capacity (FRC) to act as an oxygen reservoir during intubation, which prolongs safe apnoea time, therefore, preventing desaturation whilst an endotracheal tube (ETT) is placed.\n\nAdequate preoxygenation is especially important for those patients at highest risk of hypoxia during the RSI. This patient group includes those with underlying lung pathology e.g. pneumonia, patients with increased metabolic demand e.g. sepsis, patients with an oxygen requirement prior to RSI, or patients with underlying conditions that predisposes to hypoxia e.g. obesity.\n\nFor many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation. ETO2 measures the exhaled oxygen concentration and is a marker of the oxygen concentration in the alveoli. Prior to induction, anaesthetists most commonly preoxygenate with a face-mask seal via either a circle circuit, Mapleson circuit, or bag valve mask. ETO2 provides an objective measurement of preoxygenation efficacy. The Difficult Airway Society guidelines suggest aiming for an ETO2 of ≥87% prior to commencing RSI.(7) ETO2 levels are not routinely measured in Emergency Departments.\n\nCurrently, it is not possible to measure the effectiveness of preoxygenation in the ED. Pulse-wave oximetry reflects peripheral oxygen saturation and not the pulmonary oxygen concentration. Therefore, to attempt to optimize preoxygenation the emergency clinician currently can only use time as a surrogate. The typically recommended duration of preoxygenation is \\> 3 minutes.\n\nRecently, the investigators conducted two multi-site studies (Ethics identifier: 2019/ETH06644) that investigated the use of ETO2 in the ED.(8, 9) The first study was conducted with clinicians blinded to the ETO2 result (8). The investigators demonstrated that preoxygenation was uniformly poor with only 26% of patients achieving the required target ETO2 of ≥85%. The investigators then completed a second study where clinicians had access to ETO2 values and found that the proportion of patients reaching levels ≥85% was improved to 67% of patients. (9) The prevalence of hypoxemia (SpO2 \\<90%) in the group blinded to ETO2 was 18% (n=18, 95% CI: 11% to 27%) and was 8% in the group where ETO2 was available (n = 8, 95% CI: 4% to 15%). These studies indicate that the use of ETO2 may substantially improve preoxygenation in the ED and therefore reduce the risk of hypoxia.\n\nThese studies, however, were focused on preoxygenation practices and not patient-oriented outcomes (hypoxia) and were limited in design and resources. Consequently, it is still unclear whether the use of ETO2 in the ED leads to improved clinical outcomes.\n\nRATIONALE FOR PERFORMING THE STUDY\n\nThe aim of this study is to determine the effectiveness of ETO2 monitoring in preventing desaturation for patients with a high risk of hypoxia undergoing RSI in ED.\n\nHYPOTHESIS\n\nThe investigators hypothesise that the use of ETO2 monitoring leads to reduced rates of oxygen desaturation during the peri-intubation period compared to when it is not used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient is located in the ED resuscitation bay of the participating centre.\n2. The planned procedure is orotracheal intubation using a laryngoscope and RSI technique with preoxygenation for patients who are spontaneously breathing.\n3. The patient is deemed to be at a high risk of hypoxia during RSI as per the treating ED clinician, as defined by:\n\n * Any patient requiring any form of oxygen therapy before preoxygenation.\n * Any patient with respiratory pathology based on clinical or radiological findings. Including, but not limited to:\n\n * 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)\n * Any patient with high oxygen consumption. Including, but not limited to:\n\n * Sepsis, Diabetic ketoacidosis, alcohol or drug withdrawal, seizures, thyrotoxicosis\n * Any underlying patient condition that may predispose to hypoxemia. Including, but not limited to:\n\n * Obesity, pregnancy, underlying lung disease (e.g. asthma, pulmonary fibrosis, emphysema), severe injury- hypovolaemia/haemorrhage.\n * or any other patient that the treating clinician has a high concern for hypoxemia during RSI.\n\nExclusion Criteria:\n\n1. Patient is known to be less than 18 years old.\n2. The patient has a supraglottic device in-situ e.g iGel or LMA.\n3. The patient is known to be pregnant.\n4. The patient is known to be a prisoner.\n5. The patient was intubated in the prehospital environment.\n6. Immediate need for tracheal intubation precludes preoxygenation i.e. the patient is in cardiac arrest.'}, 'identificationModule': {'nctId': 'NCT06578468', 'acronym': 'PREOXED', 'briefTitle': 'End-Tidal Oxygen for Intubation in the Emergency Department', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sydney Local Health District'}, 'officialTitle': 'Preoxygenation Using End-Tidal Oxygen for Rapid Sequence Intubation in the Emergency Department (The PREOXED Trial) - a Multicentre Stepped Wedge Cluster Randomised Control Trial', 'orgStudyIdInfo': {'id': '24-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control period', 'description': "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."}, {'type': 'EXPERIMENTAL', 'label': 'Study period', 'description': '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.\n\nClinicians 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.', 'interventionNames': ['Device: End-tidal oxygen monitor']}], 'interventions': [{'name': 'End-tidal oxygen monitor', 'type': 'DEVICE', 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Study period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55451', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Driver, MD', 'role': 'CONTACT', 'email': 'briandriver@gmail.com'}], 'facility': 'Hennepin Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darren Braude, MD', 'role': 'CONTACT', 'email': 'DBraude@salud.unm.edu'}], 'facility': 'University of New Mexico Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicholas Caputo, MD', 'role': 'CONTACT', 'email': 'ncaputo.md@gmail.com'}], 'facility': 'Lincoln Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Andrew Coggins, MBBS', 'role': 'CONTACT', 'email': 'andrewrcoggins@gmail.com'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Matthew Oliver, MBBS', 'role': 'CONTACT', 'email': 'matthew.oliver@health.nsw.gov.au', 'phone': '+61410188680'}, {'name': 'Naomi Derrick', 'role': 'CONTACT', 'email': 'naomi.derrick@health.nsw.gov.au', 'phone': '+61457240478'}], 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ian Ferguson, MBBS', 'role': 'CONTACT', 'email': 'Ian.Ferguson@health.nsw.gov.au'}], 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Cliff Reid, MBBS', 'role': 'CONTACT', 'email': 'Cliff.Reid@health.nsw.gov.au'}, {'name': 'Brian Burns, MBBS', 'role': 'CONTACT', 'email': 'Brian.Burns@health.nsw.gov.au'}], 'facility': 'Northern Beaches Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Toby Fogg, MBBS', 'role': 'CONTACT', 'email': 'tobyfogg@mac.com'}, {'name': 'Chris Partyka, MBBS', 'role': 'CONTACT', 'email': 'chrispartyka@gmail.com'}, {'name': 'John Vassiliadis', 'role': 'CONTACT'}], 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Chris Groombridge, MBBS', 'role': 'CONTACT', 'email': 'c.groombridge@alfred.org.au'}], 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Matthew Oliver, MBBS', 'role': 'CONTACT', 'email': 'matthew.oliver@health.nsw.gov.au', 'phone': '+61410188680'}, {'name': 'Naomi Derrick', 'role': 'CONTACT', 'email': 'naomi.derrick@health.nsw.gov.au', 'phone': '+61457240478'}], 'overallOfficials': [{'name': 'Matthew Oliver, MBBS', 'role': 'STUDY_CHAIR', 'affiliation': 'Sydney Local Health District'}, {'name': 'Nick Caputo, Md', 'role': 'STUDY_CHAIR', 'affiliation': 'Lincoln Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'No end date', 'ipdSharing': 'YES', 'description': 'Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator.', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sydney Local Health District', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Specialist', 'investigatorFullName': 'Matthew Oliver', 'investigatorAffiliation': 'Sydney Local Health District'}}}}