Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT03817918
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, interventional, cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the measurement of local pleural strain using ultrasonography', 'timeFrame': 'At the end of the study on Day 1', 'description': 'Proportion of successfully analyzed lung ultrasonographic clips'}], 'secondaryOutcomes': [{'measure': 'Average absolute lateral deformation', 'timeFrame': 'At the end of the study on Day 1', 'description': 'Change in percentage from baseline expiratory values'}, {'measure': 'Cumulated range of absolute lateral deformation', 'timeFrame': 'At the end of the study on Day 1', 'description': 'Change in percentage from baseline expiratory values'}, {'measure': 'Average absolute lateral shift', 'timeFrame': 'At the end of the study on Day 1', 'description': 'Change in percentage from baseline expiratory values'}, {'measure': 'Cumulated range of absolute lateral shift', 'timeFrame': 'At the end of the study on Day 1', 'description': 'Change in percentage from baseline expiratory values'}, {'measure': 'Average von mises', 'timeFrame': 'At the end of the study on Day 1', 'description': 'Change in percentage from baseline expiratory values'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator-Induced Lung Injury', 'Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'Mechanical ventilation is frequently used in the operating room and the intensive care settings. Although essential in many cases, mechanical ventilation can be responsible for ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently observed in mechanically ventilated patients, the presence of a severe pre-existing pulmonary disease can increase the risk of overdistension. The development of a tool allowing early detection of pulmonary overdistension would represent a great asset in the prevention of VILI by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging is a non-radiant, non-invasive technique already available in the intensive care setting. Already used for cardiac strain measurements, ultrasonography is a promising avenue to assess pulmonary strain.\n\nThis pilot study will aim to create a small dataset of local pleural strain values assessed at predetermined pulmonary areas using ultrasound imaging in patients undergoing thoracic surgery requiring one-lung ventilation. This dataset will be used to help plan larger scale studies.', 'detailedDescription': "At four different time points during thoracic surgery, images of the pleura of the dependent lung will be made at 2 predetermined areas. The images will be made: after induction (tidal volume of 10 mL/kg), during two-lung ventilation (tidal volume of 10 mL/kg) and during one-lung ventilation (tidal volume of 10 mL/kg and 5 mL/kg). The sites to be studied will be: the 3rd intercostal space at the mid-clavicular line (dependent lung), the 8th intercostal space at the posterior axillary line (dependent lung). Three consecutive respiratory cycles at each site will be recorded for subsequent analysis.\n\nLung ultrasonography will be performed by the principal investigator and a co-investigator using a Terason (Teratech Corporation, Burlington, MA) device and a 12L5 linear ultrasound probe. For each image, the probe will be oriented perpendicularly to the pleura with the pointer towards the participant's head. A depth of 4 cm will be used and adjusted in order to have the pleural line located between the center and the three-quarts of the screen. The beam's focal zone will be positioned at the level of the pleural line. A 12 MHz frequency will be used.\n\nUsing a reference ultrasonographic image, an experienced lung ultrasonographer will segment the pleura. From this image, an algorithm will define a region of interest which will be followed throughout the rest of the images of the video sequence. Thereafter, the algorithm will calculate the various components of pulmonary strain in relation to tidal volume. The principal investigator or a co-investigator will visually validate the speckle-tracking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing thoracic surgery in lateral position requiring one-lung ventilation\n\nExclusion Criteria:\n\n* Obesity (Body Mass Index superior to 30 kg/m2)\n* Emergency surgery\n* Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)\n* Previous participation to the study\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT03817918', 'acronym': 'STRAIN-VUP', 'briefTitle': 'A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia Using One-lung Ventilation.', 'orgStudyIdInfo': {'id': '18.304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Determination of local pleural strain', 'description': 'The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography', 'interventionNames': ['Procedure: Lung ultrasonography']}], 'interventions': [{'name': 'Lung ultrasonography', 'type': 'PROCEDURE', 'description': 'Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points', 'armGroupLabels': ['Determination of local pleural strain']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Martin Girard, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}