Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05200494
Status:
UNKNOWN
Last Update Posted:
2022-01-20
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be masked since he/she will be not present at the end of the procedure, when the intervention (Recruiting Maneuver) will be applied or not.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive or not a Recruiting Maneuver (RM) at the end of the Flexible Bronchoscopy. RM will be performed by the application to the airways of 30 cmH2O positive pressure for 30 seconds.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Aeration through EIT', 'timeFrame': 'One hour after the end of the bronchoscopy', 'description': 'Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)'}, {'measure': 'Lung Aeration through Lung Ultrasound', 'timeFrame': 'One hour after the end of the bronchoscopy', 'description': 'Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)'}], 'secondaryOutcomes': [{'measure': 'Arterial Blood Gases', 'timeFrame': 'Soon after the end of the bronchoscopy', 'description': 'Arterial Blood Gases will be assessed through an arterial blood sample'}, {'measure': 'Arterial Blood Gases', 'timeFrame': 'One hour after the end of the bronchoscopy', 'description': 'Arterial Blood Gases will be assessed through an arterial blood sample'}, {'measure': 'Lung Aeration through EIT', 'timeFrame': 'Soon after the end of the bronchoscopy', 'description': 'Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)'}, {'measure': 'Lung Aeration through Lung Ultrasound', 'timeFrame': 'Soon after the end of the bronchoscopy', 'description': 'Improvement of lung aeration will be assess with Lung Ultrasound Score , as compared to baseline (before the bronchoscopy)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secretions', 'Bronchoscopy', 'Lung Ultrasound', 'Electrical Impedance Tomography'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'In patients suffering from acute respiratory failure, ineffective cough and the consequent retention of secretions are common clinical problems, which often lead to the need for tracheostomy for the sole purpose of aspiration of secretions from the airways.\n\nMechanically ventilated critically ill patients often have impaired mucus transport which is associated with secretion retention and subsequent development of pneumonia. The accumulation of tracheobronchial secretions in ventilated patients in ICU is due not only to an increased production, but also to a decreased clearance. In the event that secretions occlude a bronchus, an atelectasis of the lung parenchyma is created downstream. Therefore, it is often necessary to perform a flexible bronchoscopy (FOB) to proceed with the removal of the secretion plug. After its removal, the lung is supposed to be reventilated and recruited.\n\nIn intubated ICU patients, the application of a recruiting maneuver (RM) is commonly used to reopen the collapsed lung in patients with Acute Respiratory Distress Syndrome or in case of atelectasis in other clinical conditions. However, no studies have so far investigated the role of the application of a RM after a FOB performed to remove a secretion plug in intubated ICU patients.\n\nThis observational and physiological study aims to assess if the application of a RM would modify the lung aeration soon after an FOB to remove secretion plug (first outcome). Moreover, the study aims to assess if EIT could be an additional bedside imaging tool to monitor modifications of lung ventilation and aeration during and after a flexible bronchoscopy, as compared with both chest-X-ray and lung ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invasive mechanical ventilation\n* need for flexible bronchoscopy to remove secretion plug from the airway\n\nExclusion Criteria:\n\n* hemodynamic instability, (i.e. systolic arterial pressure \\<90 mmHg or mean systolic pressure \\<65 mmHg despite fluid repletion);\n* need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine \\>0.3 mcg/kg/min or dobutamine\\>5 mcg/kg/min;\n* life-threatening arrhythmias or electrocardiographic signs of ischemia;\n* contraindications to placement of Electrical Impedance Tomography belt, Lung UltraSound or application of a Recruiting Maneuver (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week);\n* inclusion in other research protocols.'}, 'identificationModule': {'nctId': 'NCT05200494', 'briefTitle': 'Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'Assessment of Lung Aeretion After Flexible Bronchoscopy for Secretion Removal in Intubated Critically Ill Patients Receiving or Not a Recruiting Maneuver Soon After the Procedure: an Observational Physiological Study', 'orgStudyIdInfo': {'id': 'ICU Bronchoscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Flexible Bronchoscopy without Recruiting Maneuver', 'description': 'At the end of the bronchoscopy, no further interventions or ventilator maneuvers will be done.'}, {'type': 'EXPERIMENTAL', 'label': 'Flexible Bronchoscopy with Recruiting Maneuver', 'description': 'At the end of the bronchoscopy, a recruiting maneuver will be applied to the patients. Recruiting Maneuver consists in the application of an airway pressure of 30 cmH2O for a period of 30 seconds.', 'interventionNames': ['Procedure: Recruiting Maneuver']}], 'interventions': [{'name': 'Recruiting Maneuver', 'type': 'PROCEDURE', 'description': 'Airway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy', 'armGroupLabels': ['Flexible Bronchoscopy with Recruiting Maneuver']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Catanzaro', 'country': 'Italy', 'facility': 'AOU Mater Domini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'centralContacts': [{'name': 'Federico Longhini, MD', 'role': 'CONTACT', 'email': 'longhini.federico@gmail.com', 'phone': '+393475395967'}], 'overallOfficials': [{'name': 'Federico Longhini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Magna Graecia University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After study publication on a peer-reviewed journal in english language', 'ipdSharing': 'YES', 'description': 'Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator', 'accessCriteria': 'On reasonable request to the Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Magna Graecia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Federico Longhini', 'investigatorAffiliation': 'University Magna Graecia'}}}}