Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT01580956
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2012-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"VARIABLE-PSV" Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2012-04-18', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenation in each ventilatory mode', 'timeFrame': 'after 24h of mechanical ventilation in each mode', 'description': 'We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.'}], 'secondaryOutcomes': [{'measure': 'Ventilatory comfort', 'timeFrame': 'during 24h in each mode', 'description': 'Comfort zone is defined as previously reported in some papers as considered adequate ventilation : 6 \\< tidal volume \\< 10 ml/kg, ETCO2 \\< 55 mmHg and \\< 65 mmHg for COPD patients and 12 \\< Respiratory rate \\< 35 cycles/min.'}, {'measure': 'Feasibility', 'timeFrame': 'during the 24 hours', 'description': 'Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.'}, {'measure': 'Patient/ventilator asynchronism', 'timeFrame': 'during the 24 hours', 'description': 'Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation'}, {'measure': 'Ventilatory effects', 'timeFrame': 'during the 24 hours', 'description': 'Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.'}, {'measure': 'Sleep quality', 'timeFrame': 'after the 24 hours', 'description': 'Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure', 'Critical illness', 'Mechanical ventilation', 'Ventilation weaning', 'Intensive Care Unit', 'Variable (NOISY) PSV', 'PSV'], 'conditions': ['Acute Respiratory Failure', 'Critical Illness', 'Ventilation Weaning']}, 'descriptionModule': {'briefSummary': 'Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.', 'detailedDescription': 'Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ventilation planned for more than 48 h\n* patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0\n* Age \\> or equal 18\n* Surrogate decision maker's consent\n\nExclusion Criteria:\n\n* Clinical instability for any reason.\n* Life support withdrawal code\n* Patient under tutelage\n* Pregnancy\n* No French health insurance"}, 'identificationModule': {'nctId': 'NCT01580956', 'briefTitle': '"VARIABLE-PSV" Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study', 'orgStudyIdInfo': {'id': 'UF 8897'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'VARIABLE-PSV ventilatory mode', 'interventionNames': ['Other: VARIABLE-PSV ventilatory mode']}, {'type': 'OTHER', 'label': 'STANDARD-PSV ventilatory mode', 'interventionNames': ['Other: STANDARD-PSV ventilatory mode']}], 'interventions': [{'name': 'VARIABLE-PSV ventilatory mode', 'type': 'OTHER', 'description': 'The two ventilatory modes will be studied during 24h in intubated patients in random order.', 'armGroupLabels': ['VARIABLE-PSV ventilatory mode']}, {'name': 'STANDARD-PSV ventilatory mode', 'type': 'OTHER', 'description': 'The two ventilatory modes will be studied during 24h in intubated patients in random order.', 'armGroupLabels': ['STANDARD-PSV ventilatory mode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Department of Anesthesiology & Critical Care, St Eloi University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}