Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT05538858
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2022-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057772', 'term': 'Vascular System Injuries'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2022-09-11', 'studyFirstSubmitQcDate': '2022-09-11', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative change of postoperative Granulocyte-macrophage colony-stimulating factor (GM-CSF) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interferon gamma (IFNγ) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-1β plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-1RA plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-4 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-5 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-6 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-8 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-10 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-12(p40) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-12(p70) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Interleukin-13 plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Monocyte Chemoattractant Protein-1 (MCP-1) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Tumor Necrosis Factor Alpha (TNFα) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Soluble platelet endothelial cell adhesion molecule-1 (sPECAM-1) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Vascular Cell Adhesion Molecule 1 (VCAM-1) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Vascular Endothelial Growth Factor (VEGF) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Angiopoietin 2 (Ang-2) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Tyrosine-protein kinase receptor Tie-2 (sTIE-2) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Soluble platelet selectin (sP-selectin) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Soluble endothelial selectin (sE-selectin) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative Soluble intercellular adhesion molecule-1 (sICAM-1) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative thrombomodulin plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}, {'measure': 'Relative change of postoperative von Willebrand factor (vWF) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Relative change of postoperative Semaphorin 3E (sema3E) plasma concentration relative to preoperative plasma concentration', 'timeFrame': 'Immediately prior to surgical procedure to immediately after surgical procedure', 'description': 'Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication', 'Vascular Injury', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Investigation of the effect of mechanical ventilation on biomarkers of microvascular damage', 'detailedDescription': 'The objective of this study is to determine the effect of mechanical ventilation (MV) on endothelial biomarkers associated with ventilator-induced vascular injury (VIVI), and determine the correlation of these biomarkers with non-invasive microvascular perfusion monitoring data and semaphorin 3E levels.\n\nBlood samples will be collected immediately pre-operatively and post-operatively.\n\nBiomarkers will be expressed as an absolute value and as a relative percentage change from baseline to account for inter-individual variability. Hemodynamic and surgical variables will be extracted from the OR data: blood pressure, oxygen saturation, blood loss, fluid administration, length of surgery, and MV parameters such as tidal volume, inspired oxygen, respiratory rate, and positive end-expiratory pressure.\n\nDuring surgery, patients will be monitored using a non-invasive near-infrared spectroscopy technique to quantify skeletal muscle microvascular perfusion. These devices will be applied immediately prior to induction of anesthetic and data collected until immediately prior to transfer to the post-anesthesia care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective orthopedic, endourologic, or plastic surgery procedure amenable to both general anesthetic or regional/neuraxial anesthesia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or greater\n* Patients undergoing elective orthopedic, endourologic, or plastic surgery procedure which is amenable to both general anesthetic or regional/neuraxial anesthesia\n\nExclusion Criteria:\n\n* Emergency surgery\n* Polytrauma\n* Tourniquet use\n* Controlled hypotension\n* Mechanical ventilation less than 60 minutes in duration\n* American Society of Anesthesiologists class 4 or greater\n* Status postpneumonectomy\n* Pulmonary hypertension\n* Oxygen therapy during last month\n* Severe obesity (body mass index ≥40 kg/m2)\n* Immunosuppression within 3 months\n* Diagnosed infection\n* Shock'}, 'identificationModule': {'nctId': 'NCT05538858', 'briefTitle': 'Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study', 'orgStudyIdInfo': {'id': 'HS25427'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical Ventilation', 'description': 'Cohort will undergo standard of care treatment utilizing a general anesthetic with mechanical ventilation for a surgical procedure.', 'interventionNames': ['Procedure: Mechanical Ventilation']}, {'label': 'Control', 'description': 'Cohort will undergo standard of care treatment utilizing a regional or neuraxial anesthetic without mechanical ventilation for a surgical procedure.'}], 'interventions': [{'name': 'Mechanical Ventilation', 'type': 'PROCEDURE', 'description': 'Positive pressure mechanical ventilation', 'armGroupLabels': ['Mechanical Ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Health Sciences Center', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Asher Mendelson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Asher Mendelson', 'investigatorAffiliation': 'University of Manitoba'}}}}