Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT05403320
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2022-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter cluster randomized controlled and open-label trial. Because intubation is an urgent intervention in critically ill patients patients with acute respiratory failure, individual randomization is considered too complex and we predetermined cluster of 9 consecutive patients, stratified by centers, with each cluster being assigned to one of the study groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ventilator-associated pneumonia (number of events)', 'timeFrame': '28 days', 'description': 'The proportion of patients who develop ventilator-associated pneumonia (presence of radiological and clinical signs consisting of a new and persistent infiltrate on the chest radiograph associated with two of the three following criteria: purulent tracheal aspirates, hyperthermia \\>38 °C or hypothermia \\<36 °C and peripheral leucocytosis \\>10,000/μ l or \\<1,500/μ. A microbiological confirmation is required using tracheal aspirate ≥ 10\\^5 CFU/ml or bronchoalveolar lavage ≥ 10\\^4 CFU/ml)'}, {'measure': 'Microaspiration (number of events)', 'timeFrame': '2 days', 'description': 'The prevalence of patients with gastric and oropharyngeal microaspiration or abundant microaspiration (Microaspiration is defined by the presence of alpha-amylase \\>1685 UI/L in tracheal aspirates. Abundant microaspiration is defined by pepsin level \\>200 ng/mL in \\>30 % of tracheal aspirates during the 48 h following inclusion.)'}, {'measure': 'Ventilator-associated events (number of events)', 'timeFrame': '28 days', 'description': 'The proportion of patients who develop ventilator-associated events, defined as a sustained increase in ventilator support (minimum PEP increase \\>2.5 cm H2 O, or minimum FiO2 increase \\>15 %) after \\>2 days of stable or decrease settings'}, {'measure': 'Time to ventilator-associated pneumonia (days)', 'timeFrame': '28 days', 'description': 'The time until the first diagnosis of ventilator-associated pneumonia is established'}, {'measure': 'Antibiotic-free days (days)', 'timeFrame': '28 days', 'description': 'The number of days in which the patient is not treated with any antibiotic drug'}, {'measure': 'Ventilator-free days (days)', 'timeFrame': '28 days', 'description': 'The number of days in which patients do not receive mechanical ventilation within 28 days from randomization'}, {'measure': 'Length of intensive care unit stay (days)', 'timeFrame': '28 days', 'description': 'The number of days in which the patient is admitted in intensive care unit or in hospital'}, {'measure': 'Length of hospital stay (days)', 'timeFrame': '28 days', 'description': 'The number of days in which the patient is admitted in hospital'}, {'measure': 'In-intensive care unit mortality (number of events)', 'timeFrame': '28 days', 'description': 'All-cause mortality, assessed at the discharge from the intensive care unit'}, {'measure': 'In-hospital mortality (number of events)', 'timeFrame': '28 days', 'description': 'All-cause mortality, assessed at the discharge from the hospital'}, {'measure': '28-day mortality (number of events)', 'timeFrame': '28 days', 'description': 'All-cause 28-day mortality'}, {'measure': '60-day mortality (number of events)', 'timeFrame': '60 days', 'description': 'All-cause 60-day mortality'}, {'measure': '90-day mortality (number of events)', 'timeFrame': '90 days', 'description': 'All-cause 90-day mortality'}, {'measure': 'Tracheobronchial colonization count (number of events)', 'timeFrame': '3 days', 'description': 'The proportion of tracheal aspirates with colonization count \\>10\\^4, 10\\^5, 10\\^6, \\>= 10\\^7 CFU/mL'}, {'measure': 'Post-extubation stridor (number of events)', 'timeFrame': '1 day', 'description': 'The proportion of patients who experience stridor after extubation'}, {'measure': 'Total subglottic secretion volume', 'timeFrame': '28 days', 'description': 'The amount of secretions which has been drained from subglottic space during the enrolment'}, {'measure': 'Daily subglottic secretion volume', 'timeFrame': '1 day', 'description': 'Daily amount of secretions which has been drained from subglottic space'}, {'measure': 'Out of range cuff pressure', 'timeFrame': '28 days', 'description': 'The proportion of cuff pressure values whose are out of the safety limits'}], 'primaryOutcomes': [{'measure': 'Bacterial tracheobronchial colonization (number of events)', 'timeFrame': '3 days', 'description': 'The proportion of patients with bacterial tracheobronchial colonization (\\> 10\\^3 CFU/mL) on Day 3 after randomization, measured from tracheal aspirate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Multicenter, cluster randomized, controlled, open-label trial to assess if AnapnoGuard System can minimize tracheal microaspiration and the risk of ventilator-associated pneumonia when compared to standard treatment', 'detailedDescription': 'Maintaining the endotracheal tube (ETT) cuff appropriately inflated plays a crucial role in the management of intubated patients because overinflation may cause tracheal wall damage, ulcerations and stenosis, and underinflation may results in fluid leakage and ventilator-associated pneumonia (VAP).\n\nDuring mechanical ventilation, secretions contaminated with oropharyngeal and gastric pathogens pool in the subglottic space (tracheal region between the ETT cuff and the vocal cords) and enter the lower airways via microaspiration.\n\nSubglottic secretion drainage (SSD) reduces the incidence of VAP and can be performed intermittently or continuously, with varying efficacy and often causing secondary tracheal mucosa lesions.\n\nAnapnoGuard (AG) ETT has three dedicated lines (two suction lines and one sensing/venting/rinsing line) and can be connected to the AG 100 System, a new device which provides high-sensitive capnography of subglottic space and consequent adjustment of cuff pressure, to avoid fluid leakage and overinflation. It also evacuates secretions from the subglottic space by simultaneously rinsing/venting this space using the ETT dedicated line.\n\nThe hypothesis is that AG System may reduce the incidence of microaspiration, bacterial tracheal colonization and consequently the risk of VAP when compared to standard treatment (ETT with manually performed secretion drainage and cuff pressure control).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary intubation with the study ETT\n* Expected duration of mechanical ventilation \\>48 hours\n* Age older than 18 years\n\nExclusion Criteria:\n\n* Invasive mechanical ventilation in the last 14 days,\n* Contraindication for enteral feeding\n* Clinical evidence of inhalation before intubation\n* Pregnancy\n* Enrolling in another study that may interfere with this trial'}, 'identificationModule': {'nctId': 'NCT05403320', 'briefTitle': 'Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'An Innovative Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia. A Multicenter Cluster-Randomized Trial', 'orgStudyIdInfo': {'id': '4739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AnapnoGuard group', 'description': 'Patients intubated with AnapnoGuard endotracheal tube (polyvinylchloride tube with ellipsoidal shape, thin wall polyurethane cuff with dual suction lines and an extra venting line) which is connected to AnapnoGuard 100 System', 'interventionNames': ['Device: Continuous cuff pressure regulation', 'Device: Automatic subglottic secretion drainage', 'Diagnostic Test: Tracheobronchial colonization assessment', 'Diagnostic Test: Microaspiration assessment', 'Diagnostic Test: VAP assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)', 'interventionNames': ['Device: Intermittent cuff pressure regulation', 'Device: Manual subglottic secretion drainage', 'Diagnostic Test: Tracheobronchial colonization assessment', 'Diagnostic Test: Microaspiration assessment', 'Diagnostic Test: VAP assessment']}], 'interventions': [{'name': 'Continuous cuff pressure regulation', 'type': 'DEVICE', 'description': 'Within 24 hours, AnapnoGuard tube will be connected to AnapnoGuard 100 control device. It includes an automatic high-sensitive subglottic capnograph which measures every few minutes the carbon dioxide level in the subglottic space. If the level of carbon dioxide is above the threshold (established by animal studies) the system will increase the cuff pressure by a formula, if the level is below the threshold, the system will decrease the cuff pressure by 1 mmHg. Variations of cuff pressure are allowed only between pressure limits set by the user (minimum and maximum)', 'armGroupLabels': ['AnapnoGuard group']}, {'name': 'Intermittent cuff pressure regulation', 'type': 'DEVICE', 'description': 'ET cuff pressure will be manually measured three times per day using a portable manometer, and kept constant within 20-30 cmH2O', 'armGroupLabels': ['Control group']}, {'name': 'Automatic subglottic secretion drainage', 'type': 'DEVICE', 'description': 'Within 24 hours, AnapnoGuard tube will be connected to AnapnoGuard 100 device control which provides continuous subglottic secretion drainage (two different suction lines) and venting/rinsing (a third dedicated line)', 'armGroupLabels': ['AnapnoGuard group']}, {'name': 'Manual subglottic secretion drainage', 'type': 'DEVICE', 'description': 'Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen', 'armGroupLabels': ['Control group']}, {'name': 'Tracheobronchial colonization assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture', 'armGroupLabels': ['AnapnoGuard group', 'Control group']}, {'name': 'Microaspiration assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase', 'armGroupLabels': ['AnapnoGuard group', 'Control group']}, {'name': 'VAP assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be follow to detect clinical, radiological or microbiological signs of VAP. If suspected, a tracheal aspirate or a bronchoalveolar lavage is performed to confirm the diagnosis', 'armGroupLabels': ['AnapnoGuard group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Shamir Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda ospedaliera universitaria "Policlinico di Bari"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda ospedaliera universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda ospedaliera Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda ospedaliera universitaria "Luigi Vanvitelli"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Policlinico "P. Giaccone"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Azienda ospedaliera Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico "A. GEMELLI"', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino - presidio Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Gennaro De Pascale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico A. Gemelli IRCCS'}, {'name': 'Massimo Antonelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione Policlinico A. Gemelli IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}