Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 2:57 PM
Study NCT ID:
NCT02694705
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Preoxygenation Strategies in the Prehospital Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional Expired Oxygen Concentration', 'timeFrame': '3 minutes', 'description': 'Measure of denitrogenation efficacy'}], 'secondaryOutcomes': [{'measure': 'Ease of breathing assessment using a visual analogue scale', 'timeFrame': '3 minutes', 'description': 'Visual analogue scale to assess subjective ease of breathing through each device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oxygen Inhalation Therapy', 'Intubation', 'Emergency Medicine'], 'conditions': ['Anesthesia', 'Hypoxia']}, 'referencesModule': {'references': [{'pmid': '26728311', 'type': 'BACKGROUND', 'citation': 'Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.', 'detailedDescription': 'Prospective randomised interventional study.\n\nHealthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.\n\nThe techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:\n\n1. Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.\n2. Bag-valve-mask device (BVM) with 15 l/min oxygen flow.\n3. Non-rebreather mask (NRM) device with 15 l/min oxygen flow.\n\nVolunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult volunteers\n\nExclusion Criteria:\n\n* Pregnancy\n* Respiratory disease\n* Bearded\n* Facial abnormality\n* Edentulous'}, 'identificationModule': {'nctId': 'NCT02694705', 'briefTitle': 'Assessment of Preoxygenation Strategies in the Prehospital Environment', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Assessment of Preoxygenation Strategies in the Prehospital Environment', 'orgStudyIdInfo': {'id': 'QMERC2015/69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP', 'description': '3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.', 'interventionNames': ['Device: Continuous Positive Airway Pressure (CPAP)']}, {'type': 'EXPERIMENTAL', 'label': 'BVM', 'description': '3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.', 'interventionNames': ['Device: Bag-Valve-Mask (BVM)']}, {'type': 'EXPERIMENTAL', 'label': 'NRM', 'description': '3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.', 'interventionNames': ['Device: Non-rebreather Mask (NRM)']}], 'interventions': [{'name': 'Continuous Positive Airway Pressure (CPAP)', 'type': 'DEVICE', 'description': 'CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator', 'armGroupLabels': ['CPAP']}, {'name': 'Bag-Valve-Mask (BVM)', 'type': 'DEVICE', 'description': 'Preoxygenation provided by BVM device, oxygen flow rate 15 l/min', 'armGroupLabels': ['BVM']}, {'name': 'Non-rebreather Mask (NRM)', 'type': 'DEVICE', 'description': 'Preoxygenation provided by NRM, oxygen flow rate 15 l/min', 'armGroupLabels': ['NRM']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CO6 2NS', 'city': 'Earls Colne', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Essex & Herts Air Ambulance Trust', 'geoPoint': {'lat': 51.92744, 'lon': 0.70107}}], 'overallOfficials': [{'name': 'Christopher J Groombridge, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Essex and Herts Air Ambulance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Christopher Groombridge', 'investigatorAffiliation': 'Queen Mary University of London'}}}}