Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-28 @ 10:06 PM
Study NCT ID:
NCT05295095
Status:
UNKNOWN
Last Update Posted:
2022-07-11
First Post:
2022-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Positive Pressure Extubation Reduce Postoperative Desaturation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'patients under anaesthesia at randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'desaturations during extubation', 'timeFrame': '1 minute after extubation', 'description': 'saturation \\<92%'}], 'secondaryOutcomes': [{'measure': 'desaturation postoperatory', 'timeFrame': '5 and 30 minutes after extubation', 'description': 'saturation\\<92%'}, {'measure': 'hypoxemia post operatory', 'timeFrame': '1 and 30 minutes after extubation', 'description': 'PaO2 \\<60mmHg'}, {'measure': 'atelectasis', 'timeFrame': '30 minutes after extubation', 'description': 'Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome'}, {'measure': 'awakening time', 'timeFrame': 'through extubation completion, an average 2 minutes', 'description': 'time in seconds'}, {'measure': 'use of oxygen', 'timeFrame': 'day 7', 'description': 'days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation'}, {'measure': 'post operative complications', 'timeFrame': 'day 7 and day 28', 'description': 'Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome'}, {'measure': 'feasibility and acceptance of both techniques pressure positive extubation', 'timeFrame': '15 minutes after extubation', 'description': 'questionnaire, min = 4, max =20, higher scores mean is worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['positive pressure extubation', 'Postoperative Complications', 'lung ultrasound score'], 'conditions': ['Extubation', 'Postoperative Complications', 'Lung Ultrasound Score']}, 'descriptionModule': {'briefSummary': 'Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations', 'detailedDescription': 'Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visceral or urological surgery\n* Scheduled surgery\n* Surgical or patient requirement: placement of an arterial catheter\n* Supine position\n* Post-surgical extubation scheduled in the operating room\n* Minimum age of 18 years\n* Informed and signed consent\n\nExclusion Criteria:\n\n* Severe obesity (BMI over 35kg/m2)\n* pregnant woman\n* Acute or chronic preoperative respiratory pathology.\n* Sleep apnea syndrome\n* Inability to receive informed information (does not speak, read or understand French)\n* Patient under guardianship or curatorship\n* Lack of social security coverage\n* History of intubation or criteria for difficult intubation or ventilation.'}, 'identificationModule': {'nctId': 'NCT05295095', 'acronym': 'EXTUBPOS', 'briefTitle': 'Does Positive Pressure Extubation Reduce Postoperative Desaturation?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery', 'orgStudyIdInfo': {'id': '2021_0433'}, 'secondaryIdInfos': [{'id': '2021-A03064-37', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Classical extubation technique : ETT was removed with continuous endotracheal suction'}, {'type': 'EXPERIMENTAL', 'label': 'VSPEP', 'description': 'ETT was removed with APL valve set to 20cmH2O', 'interventionNames': ['Procedure: positive pressure during extubation procedure']}, {'type': 'EXPERIMENTAL', 'label': 'VSAIPEP', 'description': 'ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room', 'interventionNames': ['Procedure: positive pressure during extubation procedure']}], 'interventions': [{'name': 'positive pressure during extubation procedure', 'type': 'PROCEDURE', 'description': 'positive pressure during extubation procedure', 'armGroupLabels': ['VSAIPEP', 'VSPEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Cédric CIRENEI, MD', 'role': 'CONTACT', 'email': 'cedric.cirenei@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Cédric CIRENEI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}