Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-20 @ 12:18 PM
Study NCT ID:
NCT00619606
Status:
COMPLETED
Last Update Posted:
2008-02-21
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-20', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prevention of hypoxia', 'prevention of hypercapnia'], 'conditions': ['Hypoxia', 'Hypercapnia']}, 'descriptionModule': {'briefSummary': 'A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels of patients during endoscopy which have used either the new oral-nasal oxygenating device (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of oxygen.', 'detailedDescription': 'Hypoxia is common during endoscopy. Following sedation induction, oxygen saturation falls moderately in most patients, whilst some drop to unacceptable levels. To monitor such changes endoscopic practices routinely use oximeters and capnography.\n\nTwinGuard is an all-in-one device which incorporates a bite block with the functionality of nasal cannula as well as monitoring expired air (carbon dioxide)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provided written fully informed consent as per protocol\n* No clinical evidence of significant respiratory conditions\n* Fasted for 6 hours prior to enrolment as per standard clinical practice for panendoscopy\n\nExclusion Criteria:\n\n* Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease\n* Patients who have a history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00619606', 'briefTitle': 'To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Trawax Pty Limited'}, 'officialTitle': 'A Randomised, Parallel, Open Label Study to Determine the Efficacy of a New Oral-Nasal Oxygenating Device (TwinGuard) Compared to Standard Bite Block Plus Nasal Cannulae', 'orgStudyIdInfo': {'id': 'CDD05/C05'}, 'secondaryIdInfos': [{'id': 'TGA CTN 089/2006'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'TwinGuard', 'type': 'DEVICE', 'description': 'A system consisting of an endoscopic bite block that fits together with a nasal cannula. After gastroscopy, the bite block is discarded leaving the patient receiving oxygen in recovery.An optional carbon dioxide sampling device fits with the TwinGuard in endoscopy to monitor expired air.'}, {'name': 'Standard endoscopic bite block', 'type': 'DEVICE', 'description': "Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth"}, {'name': 'Standard nasal cannula', 'type': 'DEVICE', 'description': 'Delivers oxygen to the nose. Tubing runs from the nose around the back of the ears and under the chin which then runs to an oxygen source.'}, {'name': 'CO2 sample line', 'type': 'DEVICE', 'description': 'Samples expired air from a patients nose. Tubing is connected to a capnograph.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas J Borody', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Digestive Diseases, Sydney'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trawax Pty Limited', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Julie Nunn', 'oldOrganization': 'Trawax Pty Ltd'}}}}