Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-03 @ 11:28 PM
Study NCT ID:
NCT06826794
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VentilO Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000142', 'term': 'Acidosis, Respiratory'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009720', 'term': 'Nurse Clinicians'}], 'ancestors': [{'id': 'D000072184', 'term': 'Nurse Specialists'}, {'id': 'D009726', 'term': 'Nurses'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with hemodynamic shock - hypotension', 'timeFrame': 'Up to extubation', 'description': 'Requiring \\>1L of volume repletion and/or use of amines at \\>0.05 mcg/kg/min or norepinephrine equivalent'}, {'measure': 'Number of participants with a barotrauma', 'timeFrame': 'Up to extubation', 'description': 'Presence of pneumothorax'}, {'measure': 'Mortality', 'timeFrame': 'Up to intensive care unit discharge', 'description': 'Intensive care unit mortality'}, {'measure': 'Intensive care unit lenght of stay', 'timeFrame': 'Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge', 'description': 'Intensive care unit lenght of stay'}, {'measure': 'Number of participants with an acute kidney injury', 'timeFrame': 'Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge', 'description': 'Acute kidney injury define by \\> 27 mmol for 48 hours or 1.5 x basline value (pre surgery)'}], 'primaryOutcomes': [{'measure': 'Respiratory acidosis', 'timeFrame': '20 minutes after initiation of mechanical ventilation', 'description': 'The frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH \\< 7.35 and PaCO2 \\> 45mmHg)'}], 'secondaryOutcomes': [{'measure': 'Acid-base disorders on arrival in intensive care', 'timeFrame': '5 minutes after initiation of mechanical ventilation', 'description': 'The frequency and severity of acid-base disorders on arrival in intensive care (pH\\<7.35 or pH \\> 7.45)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication', 'Respiratory Acidosis']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\> 18 years old)\n* Intubated patients admitted to intensive care immediately post-operatively after cardiac surgery (all cardiac surgery combined)\n* Ventilation in controlled mode (Assist Control or SIMV)\n\nExclusion Criteria:\n\n* Absence of anthropometric data (height and weight) of patients available in the patient file\n* Respiratory cycles mainly spontaneous on arrival\n* Patient extubated on arrival in intensive care'}, 'identificationModule': {'nctId': 'NCT06826794', 'acronym': 'VentilO', 'briefTitle': 'VentilO Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Frequency of Respiratory Acidosis in the Intensive Care Unit After Postoperative Cardiac Surgery. Impact of Using VentilO Application', 'orgStudyIdInfo': {'id': '2025-4300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinicians', 'description': 'Clinicians include respiratory therapists, physcians, medical students', 'interventionNames': ['Other: Clinicians']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VentilO', 'description': 'VentilO, smartphone application (or web plateform)', 'interventionNames': ['Device: VenitlO']}], 'interventions': [{'name': 'Clinicians', 'type': 'OTHER', 'description': 'Clinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.', 'armGroupLabels': ['Clinicians']}, {'name': 'VenitlO', 'type': 'DEVICE', 'description': 'VentilO application (or web platerform) will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.', 'armGroupLabels': ['VentilO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Francois Lellouche', 'role': 'CONTACT', 'email': 'francois.lellouche@criucpq.ulaval.ca', 'phone': '418-656-8711'}, {'name': 'Francois Lellouche', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Francois Lellouche Principal investigator, MD, PhD', 'role': 'CONTACT', 'email': 'francois.lellouche@criucpq.ulaval.ca', 'phone': '1-418-656-8711', 'phoneExt': '3572'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'François Lellouche', 'investigatorAffiliation': 'Laval University'}}}}