Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT06474559
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
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': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.', 'timeFrame': 'Intraoperative', 'description': 'Measured by Ventilator'}, {'measure': 'Assessment of aspiration risk by quantitative measurements of pepsin (ng/ml) and α-amylase (IU/ml) in BAL of patients and differences in its incidence between the two groups.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Measured by ELISA method'}], 'secondaryOutcomes': [{'measure': 'Differences in lung mechanics between the two patient groups', 'timeFrame': 'Intraoperative', 'description': 'Pplat cmH20( plataeu pressure) Dynamic Compliance ml/cmH20 , MAP cmH20( Mean Airway pressure ), PEEP cmH20,( positive end-expiratory pressure VTins, VTexp ( t, Raw cmH20/ml/sec( resistance of airway), ΔP cmH20(Driving Pressure, inspired (VTinsp) and expired (VTexp) tidal volumes, VTins - VTexp.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥18 years ASA1-2 who are to undergo planned urological surgery of low or intermediate severity, under general anesthesia in the lithotomy position.\n\nExclusion Criteria:\n\n* patients \\< 18 years old.\n* Patients who are going to undergo an emergency/urgent operation/ trauma patients.\n* Maternal population.\n* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.\n* Patients in whom LMA placement is contraindicated, such as patients at high risk for reflux and aspiration of gastric contents (eg, history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, morbid obesity).\n* Patients who meet at least one of the four RODS difficulty criteria.\n* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.\n* Patients who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06474559', 'briefTitle': 'Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Comparison of Protector Laryngeal Mask With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration', 'orgStudyIdInfo': {'id': 'Protector-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMA Protector', 'description': 'LMA Protector will be inserted by a researcher after standard anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale. Mini bronchoalveolar lavage will be colected at the end of the procedure', 'interventionNames': ['Device: LMA Protector', 'Device: Endotracheal tube']}, {'type': 'EXPERIMENTAL', 'label': 'Endotracheal tube', 'description': 'Patients will be intubated after standard anesthesia induction.The view of the larynx will be assessed ( Cormack Lehane system).Mini bronchoalveolar lavage will be colected at the end of the procedure', 'interventionNames': ['Device: LMA Protector', 'Device: Endotracheal tube']}], 'interventions': [{'name': 'LMA Protector', 'type': 'DEVICE', 'description': 'LMA Protector will be inserted by a researcher after standard anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale.Mini bronchoalveolar lavage will be collected before the end of the procedure', 'armGroupLabels': ['Endotracheal tube', 'LMA Protector']}, {'name': 'Endotracheal tube', 'type': 'DEVICE', 'description': 'tracheal intubation will be perform after standard anaesthetic induction. Cormack Lehane will be recorded. Mini bronchoalveolar lavage will be collected before the end of the procedure', 'armGroupLabels': ['Endotracheal tube', 'LMA Protector']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pátrai', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'General Univerisity Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'centralContacts': [{'name': 'Stella Antoniou, MD', 'role': 'CONTACT', 'email': 'stella_A@windowslive.com', 'phone': '+306994255120'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Stella Antoniou', 'investigatorAffiliation': 'University Hospital of Patras'}}}}