Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 12:49 PM
Study NCT ID:
NCT01474850
Status:
COMPLETED
Last Update Posted:
2014-12-08
First Post:
2011-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opto-electronic plethysmography (OEP)', 'timeFrame': '1. 5 min after each of these steps: the onset of the mechanical ventilation, the randomization, the end of the surgery 2. continuously during recovery 3. one hour after extubation', 'description': 'Respiratory movements and thoracic and abdominal volume changes is recorded continuously using OEP (OEP system, BTS,Milan, Italy) by analysing the movements of retro-reflective markers using six video cameras connected to an automatic optoelectronic motion analyser.'}], 'secondaryOutcomes': [{'measure': 'Functional residual capacity (FRC)', 'timeFrame': '5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery'}, {'measure': 'Oxygenation (paO2)', 'timeFrame': '5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation', 'description': 'Arterial blood gas measurement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'pressure control ventilation', 'lung recruitment', 'positive end expiratory pressure', 'opto-electronic plethysmography', 'chest wall volume variation', 'intravenous anesthesia'], 'conditions': ['Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.', 'detailedDescription': 'This is prospective, randomized clinical trial in subjects undergoing elective surgery requiring general anesthesia.\n\nOpto-electronic plethysmography (OEP) has been developed as a non-invasive method for the analysis of chest wall motion, allowing highly accurate measurements of chest wall volume changes of different respiratory compartments in various conditions.\n\nThe investigators set out to use this technology to study chest wall volume changes during recovery from total intravenous anesthesia (from discontinuing the anesthetic agent till extubation) and early postoperative period.\n\nThe study protocol compares two different approaches:\n\n1. The group receiving recruitment maneuver (RM) immediately after intubation and positive end expiratory pressure (PEEP) 7 cm H20 until extubation. Inspiratory oxygen concentration 40% during recovery from anesthesia.\n2. The group not receiving RM, PEEP 0 cm H2O and inspiratory oxygen concentration 100% during recovery from anesthesia.\n\nThe volume changes of the chest wall is monitored continuously by OEP, functional residual capacity (FRC) and arterial oxygenation are measured at the defined points in the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* ASA classification I-II, scheduled for elective surgery requiring general anesthesia\n* signed informed consent\n\nExclusion Criteria:\n\n* BMI \\> 35\n* co-existing respiratory disease (COPD, asthma )\n* patient refusal\n* pregnancy\n* deformities of the thorax'}, 'identificationModule': {'nctId': 'NCT01474850', 'briefTitle': 'Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography (OEP).', 'orgStudyIdInfo': {'id': 'Uppsala 2011 - 190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open lung', 'description': 'The lung recruitment maneuver (RM) immediately after intubation using pressure controlled ventilation, increase in peak inspiratory pressure up to 30 cm H2O during tidal ventilation, respiratory rate 4/min and positive end expiratory pressure (PEEP) 15 cm H20. PEEP 7 cm H2O until extubation. Inspiratory oxygen concentration (FiO2) 40% during recovery from anesthesia.', 'interventionNames': ['Procedure: lung recruitment maneuver']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.'}], 'interventions': [{'name': 'lung recruitment maneuver', 'type': 'PROCEDURE', 'description': 'RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)', 'armGroupLabels': ['open lung']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751 85', 'city': 'Uppsala', 'state': 'Uppsala County', 'country': 'Sweden', 'facility': 'Uppsala University Hospital, Anesthesia and Intensive care dep.', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Peter Frykholm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Politecnico di Milano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff anesthesiologist', 'investigatorFullName': 'Peter Kostic', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}