Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-04-06 @ 2:37 PM
Study NCT ID:
NCT00146250
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2005-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of N2O Administration on Arterial Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2005-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaO2', 'timeFrame': 'Minimum of 30 minutes after induction of anaesthesia', 'description': 'Measured change in PaO2 after a minimum of 30 minutes of general anaesthesia, following sternotomy, in the two groups.'}], 'secondaryOutcomes': [{'measure': 'Change in pulmonary deadspace and shunt fractions', 'timeFrame': 'Minimum of 30 minutes after induction of anaesthesia', 'description': 'Change in pulmonary deadspace and shunt fractions, as calculated by the Bohr and shunt equations.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Nitrous oxide is a standard part of most anaesthetic breathing mixtures. It has often been assumed that it reduces the amount of oxygen reaching the lower parts of the lung. However the results of previous studies and of some computer modelling suggests the opposite may be true, and that oxygen levels in the blood are actually higher with nitrous oxide. This study seeks to determine whether nitrous oxide increases or decreases blood oxygen levels in anaesthetized patients.', 'detailedDescription': 'The concentrating and second gas effects of nitrous oxide (N2O) uptake have been well described, and are produced by rapid uptake of N2O during the first several minutes of an inhalational anesthetic. This significantly increases alveolar and arterial O2 partial pressure. Theoretical modelling of alveolar gas exchange has predicted that these effects may not be transient but may be a persisting phenomenon. However, N2O is known to promote absorption atelectasis in poorly ventilated lung units.\n\nThis study, carried out pre-cardiopulmonary bypass in 20 patients undergoing coronary artery surgery, measures change in PaO2 after a minimum of 30 minutes of relaxant general anesthesia with a FIO2 of 30%. Patients are randomised to two groups. The intervention group has N2O introduced following baseline blood gas measurements, while the control group continued breathing an identical FIO2 in N2. The change in PaO2 in the two groups is the primary endpoint for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective coronary artery bypass surgery\n\nExclusion Criteria:\n\n* Age under 18 years, emergency surgery'}, 'identificationModule': {'nctId': 'NCT00146250', 'briefTitle': 'The Effect of N2O Administration on Arterial Oxygenation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Austin Health'}, 'officialTitle': 'Relationship of Oxygenation During Anaesthesia in the Presence of N2O or N2 to Mode of Ventilation', 'orgStudyIdInfo': {'id': 'H99/00835'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous oxide', 'description': 'Nitrous oxide 70% as balance gas in inspired mixture', 'interventionNames': ['Drug: Nitrous oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Nitrogen', 'description': 'Nitrogen instead of nitrous oxide 70% as balance gas in inspired mixture', 'interventionNames': ['Drug: Nitrous oxide']}], 'interventions': [{'name': 'Nitrous oxide', 'type': 'DRUG', 'otherNames': ['N2O'], 'description': 'Substitution of Nitrous oxide for Nitrogen as balance gas in inspired gas mixture', 'armGroupLabels': ['Nitrogen', 'Nitrous oxide']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philip J Peyton, MD FANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anaesthesia, Austin Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austin Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Monash University', 'class': 'OTHER'}, {'name': 'La Trobe University', 'class': 'OTHER'}, {'name': 'The Alfred', 'class': 'OTHER'}, {'name': 'University of Melbourne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dr Philip Peyton', 'investigatorAffiliation': 'Austin Health'}}}}