Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 10:02 AM
Study NCT ID:
NCT04178694
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy expenditure', 'timeFrame': 'during non-invasive ventilation', 'description': 'in kcal/day Energy expenditure will be measured using indirect calorimetry during different settings of non invasive ventilation'}], 'secondaryOutcomes': [{'measure': 'reversed combined rate of perceived exertion scale', 'timeFrame': 'during non-invasive ventilation', 'description': 'no unit, range: \\[-10 , +10\\] based on an existing scale of perceived exertion, a reverse part was added to be able to measure an improvement of respiratory exercise compared to normal state.'}, {'measure': 'respiratory rate', 'timeFrame': 'during non-invasive ventilation', 'description': 'in breaths/min'}, {'measure': 'systolic and diastolic bloodpressure', 'timeFrame': 'during non-invasive ventilation', 'description': 'in mmHg'}, {'measure': 'cardiac output', 'timeFrame': 'during non-invasive ventilation', 'description': 'in liter/min'}, {'measure': 'CO2 production of the body ( VCO2)', 'timeFrame': 'during non-invasive ventilation', 'description': 'in ml/min'}, {'measure': 'O2 consumption of the body (VO2)', 'timeFrame': 'during non-invasive ventilation', 'description': 'in ml/min'}, {'measure': 'Respiratory quotient', 'timeFrame': 'during non-invasive ventilation', 'description': 'no unit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Energy Expenditure', 'Non-invasive Ventilation', 'Metabolism']}, 'descriptionModule': {'briefSummary': 'Before inclusion in the trial. Careful medical history and medication use will be asked. Once included, 5 healthy subjects non-invasive ventilation(V60, Philips, Eindhoven, The Netherlands) will be administered at a level of positive end expiratory pressure (PEEP) of 4 cmH2O and without additional inspiratory support. Inspiratory support will then increase by 2 cmH2O every 2 minutes until 8 cmH2O is achieved for 2 minutes. The energy expenditure is measured using indirect calorimetry (Q-NRG®, Cosmed, Italy). To measure respiratory effort, the reversed RPE-scale was created for the purpose of the study. It uses the validated "rate of perceived exertion" scale (RPE-scale) which was altered by adding a reversed part. This could result in a score of -10 (no respiratory effort) until +10 ( maximal respiratory effort) where 0 represents the basal respiratory condition. Monitoring of heart rate, blood pressure and cardiac output will be done ( Nexfin®, BMEYE, Amsterdam, The Netherlands).\n\nAfter termination of the study clinical observation by principal investigator or co-investigator will be done for 15 minutes or until all side effects have worn off. If no side effects are observed, subjects will be released.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* pregnancy\n* prisoners\n* participation in interventional study in last 2 weeks before enrolment\n* Current ongoing disease:\n* Cardiac\n* respiratory\n* ear\n* nose\n* gastro-intestinal\n* neurological\n* psychiatric'}, 'identificationModule': {'nctId': 'NCT04178694', 'acronym': 'Ganesh', 'briefTitle': 'The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B.U.N. 143201940980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-invasive ventilation', 'description': 'All subjects will be submitted to non-invasive ventilation with different settings. During the whole period indirect calorimetry will be performed and haemodynamic parameters will be monitored using a non-invasive device. Reversed combined RPE scale will be asked on a regular base.', 'interventionNames': ['Device: non-invasive ventilation']}], 'interventions': [{'name': 'non-invasive ventilation', 'type': 'DEVICE', 'description': 'non-invasive ventilation will be performed on every subjects', 'armGroupLabels': ['non-invasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Universitair ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'Joop Jonckheer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}