Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT06719258
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2024-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endotracheal tube occlusion requiring emergency tube change', 'timeFrame': 'At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)', 'description': 'Under-humidification episodes are defined as follows:\n\n\\- Occurence of endotracheal tube occlusion requiring emergency tube change'}, {'measure': 'Bronchoscopy', 'timeFrame': 'At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)', 'description': 'Under-humidification episodes are defined as follows:\n\n\\- Occurence of performing a bronchoscopy for a suspected sub-occlusion (thick or sticky secretions), and the total number of bronchoscopies performed per patient'}, {'measure': 'Tracheal saline instillations', 'timeFrame': 'At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)', 'description': 'Under-humidification episodes are defined as follows:\n\n\\- Occurence of tracheal saline instillations due to sticky secretions or suspected endotracheal tube sub-occlusion'}, {'measure': 'Thick secretions', 'timeFrame': 'At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)', 'description': 'Under-humidification episodes are defined as follows:\n\n\\- Occurence of tracheal secretions describe at thick secretions (rated at 5 on the secretions scale used at the hospital) or "sticky secretions" if specified'}, {'measure': 'Change humidifier settings', 'timeFrame': 'At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)', 'description': 'Under-humidification episodes are defined as follows:\n\n\\- The number of operations required to change humidifier settings if the plate temperature is below 62 degrees Celcius (with the MR850).'}], 'secondaryOutcomes': [{'measure': 'Other elements that may be influenced by the quality of the humidification used during mechanical ventilation', 'timeFrame': 'At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)', 'description': 'These data will be collected:\n\n* mechanical ventilation time\n* length of stay in intensive care\n* ventilation pressures\n* use of bronchodilator aerosols.\n* Ambien room air temperature'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Humidifier Lung', 'Mechanical Fragility', 'Respiratory Complication']}, 'descriptionModule': {'briefSummary': 'When mechanical ventilation is initiated, a humidification method should be chosen. There is two methods: heat and humidity exchanger filters or heated humidity. The second method is recognized to be more efficient, but many external factors can influence its performance. Insufficient humidity results in observable problems, such as difficult management of respiratory secretions.\n\nThe study compare two heated humidifiers already used in ICU.\n\nData will be collected retrospectively from June 1, 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient in ICU on ventilation will be consider.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* Admitted to intensive care\n* Under invasive mechanical ventilation with the usual indications for the use of a heated humidifier (prolonged invasive mechanical ventilation and / or protective ventilation requiring high respiratory rates.\n\nExclusion Criteria:\n\n* Mechanical venitilation immediately after surgery (\\<24h)\n* Imminent extubation or planned intubation of very short duration (\\<24h)\n* Enrolled in the SAVE-ICU study in the group receiving volatile agents with the AnaConDa system.'}, 'identificationModule': {'nctId': 'NCT06719258', 'acronym': 'FP950', 'briefTitle': 'Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation: Benefit of the F & P950 Heated Humidifier: Comparison With the MR 850 on Clinical Events of Under-humidification', 'orgStudyIdInfo': {'id': '2022-3714'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MR850', 'description': '20 subjects on this heating humidifier (Fisher \\& Paykel MR850).', 'interventionNames': ['Device: MR850']}, {'label': 'FP950', 'description': '20 subjects on this heating humidifier (Fisher \\& Paykel FP950).', 'interventionNames': ['Device: FP950']}], 'interventions': [{'name': 'MR850', 'type': 'DEVICE', 'description': 'This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.', 'armGroupLabels': ['MR850']}, {'name': 'FP950', 'type': 'DEVICE', 'description': 'This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.', 'armGroupLabels': ['FP950']}]}, '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'}], 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'François Lellouche', 'role': 'CONTACT', 'email': 'francois.lellouche@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3572'}, {'name': 'Pierre-Alexandre Bouchard', 'role': 'CONTACT', 'email': 'pierre-alexandre.bouchard@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '2712'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'François Lellouche', 'investigatorAffiliation': 'Laval University'}}}}