Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT03853057
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2015-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Pressure and Gravity Affect Volumetric Capnography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007040', 'term': 'Hypoventilation'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011187', 'term': 'Posture'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2015-03-03', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.', 'timeFrame': '4 hours', 'description': 'The volunteers are breathing spontaneously with and without positive pressure support. Capnographic parameters were registered at each studied condition.'}], 'secondaryOutcomes': [{'measure': 'Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.', 'timeFrame': '4 hours', 'description': 'The volunteers are breathing spontaneously with and without positive pressure support. Electrical impedance images were taken at each studied condition.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['volumetric capnography', 'gravity', 'mechanical ventilation', 'EIT'], 'conditions': ['Hypoventilation']}, 'referencesModule': {'references': [{'pmid': '19186406', 'type': 'BACKGROUND', 'citation': 'Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.'}, {'pmid': '19517259', 'type': 'BACKGROUND', 'citation': 'Tusman G, Scandurra A, Bohm SH, Suarez-Sipmann F, Clara F. Model fitting of volumetric capnograms improves calculations of airway dead space and slope of phase III. J Clin Monit Comput. 2009 Aug;23(4):197-206. doi: 10.1007/s10877-009-9182-z. Epub 2009 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.', 'detailedDescription': 'In this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. Volumetric capnography and electrical impedance tomography (EIT) will be continuously recorded during the protocol. Different body positions were randomly tested. Analysis of global and regional distribution of ventilation using EIT will be matched with changes observed in volumetric capnography-derived parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '28 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society Anesthesia physical status I.\n* Age between 25-39 years old,\n* Body mass index between 23-28 kg/m2,\n* Non-smokers.\n\nExclusion Criteria:\n\n* Presence of pulmonary or cardiac diseases.\n* Abnormal spirometry.'}, 'identificationModule': {'nctId': 'NCT03853057', 'briefTitle': 'Positive Pressure and Gravity Affect Volumetric Capnography', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Privado de Comunidad de Mar del Plata'}, 'officialTitle': 'The Effect of Positive Pressure and Body Position on Volumetric Capnography Assessed by Electrical Impedance Tomography', 'orgStudyIdInfo': {'id': '04112014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-invasive ventilation', 'description': 'Non-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral.', 'interventionNames': ['Other: body positions']}], 'interventions': [{'name': 'body positions', 'type': 'OTHER', 'description': 'positive pressure ventilation at different body positions', 'armGroupLabels': ['non-invasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7600', 'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Privado de Comunidad', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}], 'overallOfficials': [{'name': 'Gerardo H Tusman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Privado de Comunidad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Privado de Comunidad de Mar del Plata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}