Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 10:59 AM
Study NCT ID:
NCT03453294
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2018-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2018-01-21', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress', 'timeFrame': 'Up to 2 hours after start of intervention', 'description': 'Biomarkers of oxidative stress such as Thiobarbituric acid reactive substances, Advanced Oxidation Protein Products,Reactive oxygen species and total antioxidant capacity in blood samples'}], 'secondaryOutcomes': [{'measure': 'Biomarkers of neuronal injury', 'timeFrame': 'Up to 2 hours after start of intervention', 'description': 'Biomarkers of neuronal injury and stress in blood such as S100 and Nuclear Serum Enolase'}, {'measure': 'Biomarkers of cardiac damage', 'timeFrame': 'Up to 2 hours after start of intervention', 'description': 'Biomarkers of cardiac damage in blood such as troponin and ProBNP'}, {'measure': 'Biomarkers of kidney injury', 'timeFrame': 'Up to 2 hours after start of intervention', 'description': 'Biomarkers of kidney injury in blood such as creatinine'}, {'measure': 'Markers of RNA damage', 'timeFrame': 'Up to 2 hours after start of intervention', 'description': 'Markers of RNA damage in blood'}, {'measure': 'Inflammatory response', 'timeFrame': 'Up to 2 hours after start of intervention', 'description': 'Biomarkers of Inflammatory response in blood such as cytokines and interleukins'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['THRIVE'], 'conditions': ['Anesthesia', 'Oxygen Toxicity']}, 'descriptionModule': {'briefSummary': 'Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as biological stress response detected by blood-bourne biomarkers before implementing it into clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults, \\>18 years old.\n2. Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).\n3. Capable of understanding the study information and sign the written consent.\n\nExclusion Criteria:\n\n1. American Society of Anaesthesiologist severity score \\>2\n2. New York Heart Association score \\>2\n3. Pacemaker or ICD.\n4. Body Mass Index \\>35\n5. Pregnancy\n6. Manifest cardiac failure or coronary disease\n7. Severe gastrointestinal reflux.\n8. Neuromuscular disorder'}, 'identificationModule': {'nctId': 'NCT03453294', 'acronym': 'Bio-THRIVE', 'briefTitle': 'Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Effect of Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) During Apneic Oxygenation in General Anesthesia on Biomarkers', 'orgStudyIdInfo': {'id': 'Bio-THRIVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apnoeic oxygenation using THRIVE', 'description': 'Oxygenation by apnoea oxygenation using THRIVE', 'interventionNames': ['Device: Apnoeic oxygenation using THRIVE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endotracheal intubation and mechanical ventilation', 'description': 'Ventilation and oxygenation by an endotracheal tub and mechanical ventilation', 'interventionNames': ['Device: Endotracheal intubation and mechanical ventilation']}], 'interventions': [{'name': 'Apnoeic oxygenation using THRIVE', 'type': 'DEVICE', 'description': 'Apnoeic oxygenation using THRIVE', 'armGroupLabels': ['Apnoeic oxygenation using THRIVE']}, {'name': 'Endotracheal intubation and mechanical ventilation', 'type': 'DEVICE', 'description': 'Endotracheal intubation and mechanical ventilation', 'armGroupLabels': ['Endotracheal intubation and mechanical ventilation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant, Associate Professor', 'investigatorFullName': 'Malin Jonsson Fagerlund', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}